Vivek Ramaswamy

Founder & CEO

Roivantは、新しい産業組織形態による研究開発を通じて、革新的な医薬品を迅速に開発することに注力しています。

Roivantは、革新的な医薬品と技術を患者に迅速に提供することにより、健康の改善を目指しています。

これを実現するために、私たちは「バント」(Vants)をいくつも構築しています。バントとは、人材調達、インセンティブの調整、および技術の展開に対する独自のアプローチを持つ、機敏で起業家的なバイオテクノロジーおよびヘルスケアテクノロジー企業です。

バイオ医薬品の子会社に加えて、私たちは医薬品の開発と商業化のプロセスの改善に励む技術に焦点を当てたバントも構築しています。

Roivant Sciencesの第2回年次パイプラインデーに参加する創設者兼CEOのビベク・ラマスワミー
Roivant Sciencesの第2回年次パイプラインデーに参加する創設者兼CEOのビベク・ラマスワミー
パイプライン

当社は、14の治療領域で多様な治験薬のパイプラインを有しています。

企業
治験薬
適応症
の治療領域にて
モダリティ
相試験
エンザイバント
RVT-802
小児先天性無胸腺症
まれな病気
再生療法
第三相試験

Congenital athymia is a rare and deadly condition where children are born without a functional thymus, an essential part of the immune system, which leads to severe primary immunodeficiency.

Currently, there are no approved FDA therapies for the congenital athymia. Enzyvant is seeking FDA approval of RVT-802, an investigational tissue-based regenerative therapy designed to reconstitute the immune system for the treatment of T cell immunodeficiency resulting from congenital athymia. RVT-802 is the first program to be granted both Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy by the FDA.

Enzyvant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at enzyvant.com

マイオバント
Relugolix
前立腺がん
腫瘍学
小分子
第三相試験

Prostate cancer is a malignant transformation of tissue within the male prostate gland. Often characterized by slow growth, prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the United States. Approximately 2.9 million men in the United States are currently living with prostate cancer, and 180,000 men are newly diagnosed each year.

By suppressing the gonadotropin luteinizing hormone (LH) and follicle-stimulating hormone (FSH), relugolix decreases prostate-specific antigen (PSA) levels in men with advanced prostate cancer. Following positive Phase 3 results announced in 2019, Myovant submitted a New Drug Application submission to the U.S. Food and Drug Administration in April 2020.

Myovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at myovant.com

マイオバント
Relugolix
子宮筋腫
女性の健康
小分子
第三相試験

Uterine fibroids are non-cancerous tumors that develop from the muscle and connective tissue of the uterus. Approximately 25% of women of reproductive age have uterine fibroids, and 1 in 4 experience symptoms requiring treatment.

Relugolix is an investigational oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. In 2019, Myovant reported positive top-line results from the LIBERTY 1 and LIBERTY 2 Phase 3 trials testing once-daily relugolix combination therapy in women with uterine fibroids. In March 2020, Myovant filed an MAA in Europe for relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids. Myovant plans to submit an NDA to the FDA in May 2020.

Myovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at myovant.com

ウロバント
Vibegron
過活動膀胱
泌尿器科
小分子
第三相試験

Bladder filling involves the relaxation of the smooth bladder muscle and contraction of the urethral smooth muscle, while voiding involves contracting the bladder muscle and relaxation of the urethral muscle. Urovant’s investigational product candidate, vibegron, is an oral, once-daily, small molecule that selectively activates the beta-3 receptor, the most prevalent beta-adrenergic receptor subtype on the smooth muscle around the bladder. Studies of isolated human bladder smooth muscle have shown that selective activation of the beta-3 adrenergic receptor results in smooth muscle relaxation. Therefore, beta-3 stimulation can increase bladder capacity and reduce the symptoms of overactive bladder (OAB).

In March 2019, Urovant announced positive topline results from an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial. Urovant’s New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) in March 2020 and was assigned a Prescription Drug User Free Act (PDUFA) with a goal date of December 26, 2020.

Urovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at urovant.com

ウロバント
Vibegron
良性前立腺過形成の男性における過活動膀胱
泌尿器科
小分子
第三相試験

Benign Prostatic Hyperplasia (BPH) is characterized by prostate enlargement, which can block the urethra and prevent normal urine flow, and is progressive with age. Approximately 40 million men between the ages of 50 and 80 in the United States suffer with BPH. In addition, approximately 50% of BPH patients also suffer from overactive bladder. However, medications used to treat BPH do not address OAB symptoms.

Urovant has initiated an international Phase 3 trial to evaluate the safety and efficacy of vibegron for symptoms of overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH). Vibegron is an investigational beta-3 agonist that has previously been evaluated in Phase 2b and Phase 3 studies in patients with overactive bladder.

Urovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at urovant.com

デルマバント
Tapinarof
乾癬
皮膚科
小分子
第三相試験

Tapinarof is an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis. It has been evaluated as a topical therapy in multiple Phase 1 and Phase 2 studies involving over 800 human subjects. In a double-blind, placebo-controlled, global Phase 2b dose-ranging study that enrolled 227 adults with plaque psoriasis, tapinarof demonstrated clinically meaningful, dose-dependent improvements over vehicle on the primary endpoint of the study. The most frequently reported adverse events were folliculitis, contact dermatitis and headache.

PSOARING is Dermavant’s pivotal Phase 3 psoriasis clinical program for tapinarof, which consists of two parallel group studies—PSOARING 1 and PSOARING 2—to evaluate the safety and efficacy of tapinarof cream 1% dosed once daily (QD) for 12 weeks versus vehicle in adult patients aged 18-75 years diagnosed with plaque psoriasis.

The primary endpoint of both studies will be a Physician Global Assessment (PGA) score assessment of “clear” skin (score of 0) or “almost clear” skin (score of 1), plus at least a 2-grade improvement from baseline, at Week 12. Following the 12-week, vehicle-controlled portion of the PSOARING trials, patients will have the option to enroll in a separate, open-label extension study for an additional 40 weeks of treatment.

Learn more at dermavant.com

マイオバント
Relugolix
子宮内膜症
女性の健康
小分子
第三相試験

Endometriosis is a gynecological medical condition in which cells that normally line the uterus grow outside of the uterine cavity. During the menstrual cycle, endometriosis lesions grow, differentiate, and shed into the abdomen, causing symptoms including non-menstrual pelvic pain and pain during menstruation (dysmenorrhea). An estimated 7.5 million women in the United States have endometriosis, and 3 in 4 experience symptoms requiring treatment.

Relugolix is an investigational oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. In April 2020, Myovant reported positive top-line results from the SPIRIT 2 Phase 3 trial testing once-daily reglugolix combination therapy in women with endometriosis. Myovant plans to report top-line results from the replicate SPIRIT 1 trial later in the second quarter of calendar year 2020.

Myovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at myovant.com

シノバント
Lefamulin
市中肺炎
感染症
小分子
第三相試験

Sinovant is initially developing lefamulin for community-acquired pneumonia, one of the leading causes of mortality in Mainland China. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat community-acquired pneumonia, and low propensity for bacterial resistance to develop, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of community-acquired pneumonia.

Lefamulin has successfully completed two global Phase 3 studies in patients with moderate and severe community-acquired pneumonia. Lefamulin has been granted Qualified Infectious Disease Product (QIDP) designation from the US FDA and is currently in preparation for an MAA in Europe.

In June 2019, the China National Medical Products Administration approved Sinovant’s Clinical Trial Application for lefamulin. In August 2019, Sinovant’s partner Nabriva Therapeutics received FDA approval of lefamulin to treat community-acquired bacterial pneumonia.

Learn more at sinovant.com

シノバント
Derazantinib
肝内胆管がん
腫瘍学
小分子
第三相試験

Sinovant is initially developing derazantinib, a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, for the treatment of intrahepatic cholangiocarcinoma (iCCA), a devastating form of biliary tract cancer with high incidence in Greater China and parts of Asia and no approved therapies. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy.

Derazantinib is currently being evaluated in a registration-enabling study in patients with FGFR2 fusion-positive second-line iCCA in the United States and Europe.

Learn more at sinovant.com

シノバント
SNV-003
遷延性移植片機能障害
腎臓学
小分子
第三相試験

Delayed graft function (DGF) is a form of acute kidney injury that manifests postoperatively in 20-30% of renal transplantation patients globally and is associated with a 40% decrease in long-term graft survival. In Greater China, persistent organ shortages have led to greater use of deceased donor kidneys, which is expected to drive increases in observed rates of DGF.

SNV-003 is an investigational small molecule mimetic of hepatocyte growth factor (HGF) being developed by Sinovant in Greater China for DGF.

Learn more at sinovant.com

シノバント
SNV-003
急性腎障害
腎臓学
小分子
第二相試験

Acute kidney injury (AKI) is characterized by an abrupt loss of kidney function and may be caused by a variety of factors. In the surgical setting, AKI is a common complication of open-heart surgery requiring cardiopulmonary bypass. Up to 30% of patients recovering from open-heart surgery experience an AKI-associated complication, resulting in a five-fold increased risk of death during hospitalization. Risk factors for AKI in the post-surgical setting include existing kidney disease, compromised heart function, exposure to nephrotoxic drugs, advanced age, and diabetes.

SNV-003 is an investigational small molecule mimetic of hepatocyte growth factor (HGF) which Sinovant plans to develop in Greater China for Acute Kidney Injury.

Learn more at sinovant.com

シノバント
Lefamulin
ABSSSI
感染症
小分子
第二相試験

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) are a group of common types of infections and include abscesses, cellulitis, and wound infections most commonly caused by gram-positive bacteria. ABSSSIs have placed an increasing burden on healthcare systems worldwide over the last 25 years, in large part due to the increasing spread and persistence of methicillin-resistant S. aureus (MRSA) strains. There were an estimated 14 million ABSSSI cases in China in 2018.

Lefamulin is a novel antibiotic of the pleuromutilin class whose mechanism of action leads to a low cross-resistance profile with other antibacterial agents. Lefamulin is currently in Phase 2 development for the treatment of ABSSSI. In August 2019, Sinovant’s partner Nabriva Therapeutics received FDA approval of lefamulin to treat community-acquired bacterial pneumonia.

Learn more at sinovant.com

シノバント
Naronapride
便秘
胃腸疾患
小分子
第二相試験

Sinovant is initially developing naronapride, a novel prokinetic agent that accelerates gastric emptying and intestinal transit, for the treatment of irritable bowel syndrome – constipation (IBS-C), a disease that affects millions of Chinese patients and for which few effective treatment options are available.

Naronapride has been evaluated in over 900 subjects in multiple randomized controlled clinical studies and has demonstrated promising results in patients with gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and chronic idiopathic constipation (CIC). Naronapride’s low systemic absorption and high receptor specificity is thought to improve its safety and tolerability profile relative to other members of the class.

Learn more at sinovant.com

アルタバント
Rodatristat Ethyl
肺動脈性高血圧
呼吸器疾患
小分子
第二相試験

Pulmonary arterial hypertension (PAH) is a rare disease that affects the arteries in the lungs and the right side of the heart by impeding blood flow through the lungs and raising pressure within the arteries. PAH is a progressive, life-threatening illness.

Rodatristat ethyl, a tryptophan hydroxylase (TPH) inhibitor that blocks the body’s peripheral production of serotonin, is currently in clinical development for pulmonary arterial hypertension with a number of additional indications being explored.

Altavant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at altavant.com

アルバント
ARU-1801
鎌状赤血球病
血液学
遺伝子治療
第二相試験

ARU-1801 is an investigational gene therapy for sickle cell disease and β-thalassemia. ARU-1801 utilizes proprietary technology intended to increase functioning red blood cells by inserting a modified fetal hemoglobin gene into autologous stem cells through a lentiviral vector. Studies have indicated that sickle cell patients with elevated levels of fetal hemoglobin have fewer vaso-occlusive crises and hospitalizations. 

ARU-1801 was developed in the laboratory of Dr. Punam Malik, Director of the Cincinnati Comprehensive Sickle Cell Center at Cincinnati Children’s. Preliminary clinical data from an ongoing Phase 1/2 study of ARU-1801 in patients with sickle cell disease conducted using a reduced-intensity conditioning (RIC) regimen enabled by the unique properties of modified fetal hemoglobin was presented by Dr. Malik in an oral presentation on Monday, December 3rd, 2018, at the Annual Meeting and Exposition of the American Society of Hematology in San Diego, CA.

Learn more at aruvant.com

アクソバント
AXO-LENTI-PD
パーキンソン病
神経学
遺伝子治療
第二相試験

AXO-Lenti-PD is an investigational gene therapy for Parkinson’s disease that delivers three genes via a single lentiviral vector to encode a set of critical enzymes required for dopamine synthesis, with the goal of reducing variability and restoring steady levels of dopamine in the brain. The gene therapy aims to provide patient benefit for years following a single administration.

Axovant announced positive 12-month data results from the first cohort of patients in its ongoing SUNRISE-PD Phase 2 trial of AXO-Lenti-PD in January 2020 and announced positive initial 6-month data from the second cohort of patients in February 2020.

Learn more at axovant.com

サイトバント
CVT-DC-01
急性骨髄性白血病
腫瘍学
細胞療法
第二相試験

CVT-DC-01 is a dendritic cell vaccine being developed for post-remission acute myeloid leukemia. Dendritic cell vaccines are patient-derived therapies in which a patient’s own dendritic cells are loaded with tumor antigens to elicit immune responses against cancerous cells. Different tumor antigens can be loaded into dendritic cells to treat various forms of cancer. As DC vaccines are designed to activate immune responses against tumor antigens over the course of vaccine administration, these therapies may be particularly suitable for cancer patients for whom prevention of disease relapse is the main treatment goal.

Learn more at cytovant.com

デルマバント
Cerdulatinib
白斑
皮膚科
局所
第二相試験

Cerdulatinib is a topical dual janus kinase (JAK) and spleen tyrosine kinase (Syk) inhibitor. Dermavant is developing cerdulatinib as a topical therapy for a variety of dermatologic conditions. Dermavant believes that the profile of cerdulatinib is ideal for development in skin diseases where a growing body of evidence suggests that both JAK and Syk are important drivers of disease manifestation.

Learn more at dermavant.com

デルマバント
Tapinarof
アトピー性皮膚炎
皮膚科
局所
第二相試験

Tapinarof is an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis. It has been evaluated as a topical therapy in multiple Phase 1 and Phase 2 studies involving over 800 human subjects.

In a double-blind, placebo-controlled global phase 2b dose-ranging study that enrolled 247 patients with atopic dermatitis, tapinarof demonstrated clinically meaningful, dose-dependent improvements over vehicle on the primary endpoint of the study. Tapinarof was generally well tolerated. The most frequently reported adverse events were folliculitis, contact dermatitis and the common cold. Efficacy assessments were made on a modified intent-to-treat population.

Learn more at dermavant.com

イミュノバント
IMVT-1401
温暖な自己免疫性血解性貧血
免疫学
生物学の
第二相試験

Warm autoimmune hemolytic anemia (WAIHA) is a rare hematologic disease in which autoantibodies mediate hemolysis, or the destruction of red blood cells. WAIHA approximately affects 42,000 people in the United States and 66,000 people in Europe. The clinical presentation is variable and most commonly includes non-specific symptoms of anemia such as fatigue, weakness, skin paleness, and shortness of breath. Symptoms typically develop chronically over several weeks to months, but rapid progression over a span of days has also been observed.

Immunovant is developing IMVT-1401, a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn), for the treatment of immunoglobulin G (IgG) mediated diseases, such as WAIHA. IMVT-1401 is being developed as a subcutaneous injection, providing a convenient and minimally invasive treatment option for patients.

Learn more at immunovant.com

イミュノバント
IMVT-1401
重症筋無力症
免疫学
生物学の
第二相試験

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by weakness and fatigue of voluntary muscles. Symptoms typically emerge in the eyes (e.g., drooping eyes, double-vision, blurred vision) and progress into the face, throat, and limbs. MG is a rare disease that affects approximately 65,000 people in the United States and 104,000 people in Europe, with a greater prevalence among younger women and older men.

The chronic nature of MG requires patients to cope with fluctuating symptoms and multiple treatment regimens for management. Persistent muscle weakness associated with MG often negatively interferes with patients’ ability to engage in daily and physical activities, including demands of work, family, and social functions.

Immunovant is developing IMVT-1401, a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn), for the treatment of immunoglobulin (IgG) mediated diseases, such as MG. IMVT-1401 is being developed as a subcutaneous injection, providing a convenient and minimally invasive treatment option for patients.

Learn more at immunovant.com

イミュノバント
IMVT-1401
甲状腺の目の病気
免疫学
生物学の
第二相試験

Thyroid eye disease (TED), also known as Graves’ ophthalmopathy, is an autoimmune disorder that affects the muscles and other tissues around the eyes. TED approximately affects 33,000 people in the United States and 52,000 people in Europe. Moderate-to-severe TED is characterized by swelling and redness of the eyelids, proptosis (protrusion of the eyeball), double vision, and, in severe cases, corneal ulceration and decreased visual acuity.

Immunovant is developing IMVT-1401, a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn), for the treatment of immunoglobulin (IgG) mediated diseases, such as TED. IMVT-1401 is being developed as a subcutaneous injection, providing a convenient and minimally invasive treatment option for patients.

Learn more at immunovant.com

メタバント
RVT-1501
糖尿病
心血管疾患
小分子
第二相試験

RVT-1501 is the first clinical candidate in a new chemical class of oral agents called the glimins by the World Health Organization. In several studies conducted to date, RVT-1501 has demonstrated potential glucose-lowering effects through increased insulin secretion in response to glucose, increased insulin sensitivity, and suppression of gluconeogenesis. RVT-1501's mechanism of action also has the potential to prevent diastolic dysfunction and to provide protective effects on beta cell survival and function.

A dozen clinical trials studying imeglimin in patients with T2D have met their primary and secondary endpoints, including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo with a favorable side effect profile. Metavant aims to initiate a Phase 3 program in patients with type 2 diabetes and chronic kidney disease (CKD) stages 3b/4 in the US and Europe. In December 2019, Poxel and Sumitomo Dainippon Pharma (DSP) announced positive Phase 3 results of imeglimin for the treatment of T2D in Japan.

Learn more at metavant.com

マイオバント
MVT-602
女性不妊
女性の健康
合成ペプチド
第二相試験

Approximately 25% of infertile women have problems related to ovulation, including the inability to produce fully matured eggs or release an egg from the ovary, referred to as anovulation. In the course of treating infertility related to anovulation, fertility specialists use a group of medications to temporarily correct ovulatory problems and increase a woman’s chance for pregnancy. These and related procedures are broadly termed Assisted Reproductive Technology, or ART. According to the CDC, approximately 208,000 cycles of ART were performed in the US in 2014, with millions more performed worldwide.

Myovant is developing MVT-602, an oligopeptide kisspeptin agonist, as a potential treatment for female infertility in women as part of assisted reproduction. In August 2019, Myovant Sciences completed a successful dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602 in healthy women undergoing a minimal controlled ovarian stimulation protocol. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired luteinizing hormone surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol.

Myovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at myovant.com

レスピバント
RVT-1601
咳を伴う特発性肺線維症
呼吸器疾患
薬物とデバイスの組み合わせ
第二相試験

RVT-1601 (formerly PA101) is a novel formulation of inhaled cromolyn sodium delivered through a proprietary nebulizer device designed to yield high lung deposition and distribution. In a completed Phase 2a trial, RVT-1601 demonstrated a statistically significant reduction in daytime and 24-hour cough frequency among idiopathic pulmonary fibrosis (IPF) patients versus placebo after 14 days of treatment. This reduction was supported by positive trends in cough-specific quality of life and cough severity, as assessed by patients in the study. 

Learn more at respivant.com

ウロバント
Vibegron
過敏性腸症候群に伴う痛み
泌尿器科
小分子
第二相試験

Irritable bowel syndrome (IBS) is characterized by recurrent abdominal pain associated with two or more of the following: defecation, a change in frequency of stool and a change in form or appearance of stool. Additionally, IBS presents a significant health care burden and can severely impair a patient’s quality of life. There are no currently marketed drugs indicated specifically for IBS-associated pain.

Urovant has initiated a U.S. clinical program for vibegron for pain associated with irritable bowel syndrome (IBS) in women. Vibegron is an investigational beta-3 agonist that has previously been evaluated in Phase 2b and Phase 3 studies in patients with overactive bladder.

Urovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at urovant.com

アクソバント
AXO-AAV-GM1
GM1-ガングリオシドーシス
神経学
遺伝子治療
第二相試験

AXO-AAV-GM1 delivers a functional copy of the GLB1 gene via an adeno-associated viral (AAV) vector, AAV9, which is effective in crossing the blood-brain barrier and transducing neurons, with the goal of restoring β-gal enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease.

In preclinical studies, AXO-AAV-GM1 was shown to improve β-gal enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival. Magnetic resonance imaging (MRI) of felines with GM1 gangliosidosis treated with AXO-AAV-GM1 showed normal brain architecture through at least two years of age.

Learn more at axovant.com

アクソバント
AXO-AAV-GM2
テイ=サックス病とサンドホフ病
神経学
遺伝子治療
第二相試験

AXO-AAV-GM2 delivers functional copies of the HEXA and HEXB genes via two, co-administered AAVrh8 vectors delivered directly to the central nervous system with the goal of restoring Hex A enzyme activity to address both Tay-Sachs and Sandhoff diseases. The preclinical data for AXO-AAV-GM2 in murine models showed dose-dependent increases in Hex A enzyme activity, reductions of GM2 gangliosides in the brain and prolonged survival rates.

Initial data with AXO-AAV-GM2 suggest stabilization of disease course, attainment of normal developmental milestones, and improvement in myelination on brain MRI.

Learn more at axovant.com

アルタバント
Rodatristat Ethyl
特発性肺線維症
呼吸器疾患
小分子
第一相試験

Idiopathic pulmonary fibrosis is an interstitial lung disease that is diagnosed in approximately 22,000 people annually in the U.S. Its incidence is higher in men than women. Median survival for patients with IPF can be less than 3.5 years from diagnosis.

It is believed that genetic mutations, environmental pollutants, certain medications and autoimmune diseases may play a role in IPF, but the root cause of the disease remains unknown. IPF is currently treated with antifibrotic agents but their effectiveness is limited, and mortality remains high.

Rodatristat ethyl, a tryptophan hydroxylase (TPH) inhibitor that blocks the body’s peripheral production of serotonin, is currently in clinical development for idiopathic pulmonary fibrosis with a number of additional indications being explored.

Altavant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at altavant.com

アルタバント
Rodatristat Ethyl
サルコイドーシス
呼吸器疾患
小分子
第一相試験

Sarcoidosis is a multi-organ disorder caused by an exaggerated immune response to an unknown antigen leading to formation of granulomas (nodules of inflamed tissue) along lymphatic tracts, most commonly in the lung, heart, skin, eyes and joints. The granulomas that develop become encased in fibroblasts, which infiltrate the involved organs, potentially leading to fibrotic organ damage.

While most sarcoidosis patients experience an acute form of the disease, approximately 20% of sarcoidosis patients develop a chronic form of the disease and approximately 5% progress to advanced pulmonary disease, which accounts for most of the morbidity and mortality associated with sarcoidosis.

Currently, there are no approved treatments or treatment algorithms specifically for sarcoidosis. Rodatristat ethyl, a tryptophan hydroxylase (TPH) inhibitor that blocks the body’s peripheral production of serotonin, is currently in clinical development for sarcoidosis with a number of additional indications being explored. ­­­­

Altavant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at altavant.com

デルマバント
DMVT-504
原発巣多汗症
皮膚科
小分子
第一相試験

DMVT-504 is a combination of the muscarinic antagonist oxybutynin with the muscarinic agonist pilocarpine. DMVT-504 uses proprietary technology to control the release and dosing of pilocarpine with the goal of reducing the frequency and severity of dry mouth and potentially other side effects associated with oxybutynin.

Learn more at dermavant.com

デルマバント
Cerdulatinib
アトピー性皮膚炎
皮膚科
局所
第一相試験

Cerdulatinib is a topical dual janus kinase (JAK) and spleen tyrosine kinase (Syk) inhibitor. Dermavant is developing cerdulatinib as a topical therapy for a variety of dermatologic conditions. Dermavant believes that the profile of cerdulatinib is ideal for development in skin diseases where a growing body of evidence suggests that both JAK and Syk are important drivers of disease manifestation.

Learn more at dermavant.com

ウロバント
URO-902
過活動膀胱
泌尿器科
遺伝子治療
第一相試験

URO-902 is a novel investigational gene therapy for patients with overactive bladder (OAB) symptoms who have failed oral pharmacologic therapy. URO-902 has been evaluated in two Phase 1 studies in OAB patients including a small, double-blind, placebo-controlled Phase 1b clinical trial as an intravesical injection in women with overactive bladder symptoms. Ion Channel Innovations completed the Phase 1b study in 2017 and found URO-902 to be generally well tolerated. Clinical results of the trial, which included a limited number of patients, indicated dose-dependent improvements in urinary urgency and frequency, achieving statistical significance in the high dose cohort.

Urovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at urovant.com

サイトバント
CVT-TCR-01
悪性腫瘍
腫瘍学
細胞治療
前臨床

CVT-TCR-01 is a T cell receptor therapy being developed for the treatment of solid tumors. T cell receptor therapies utilize a patient’s own immune system to target tumor cells. In preparation for the therapy, a patient’s T cells are modified to express tumor-specific receptors that are then able to activate and mount an antitumor response. Through ex-vivo modification of a patient’s T cells, T cell receptor therapies can overcome natural T cell tolerance toward cancer cells and tumor-induced immunosuppression. Unlike CAR-T therapy, TCR-T therapy is designed to recognize intracellular antigens in addition to extracellular antigens, which may increase the number of tumors that can be successfully targeted.

Learn more at cytovant.com

デルマバント
DMVT-501
アトピー性皮膚炎
皮膚科
小分子
前臨床

Atopic dermatitis is a chronic, pruritic inflammatory skin disease that occurs primarily in children. Both environmental and genetic factors drive disease pathology, which is characterized by breakdown of the skin barrier and concurrent inflammation. Atopic dermatitis progresses in a chronic intermittent fashion, and is characterized by periods of acute symptom worsening, known as flares, followed by periods of quiescence. Flares can be triggered by a variety of factors including infections, heat, sweating, food allergies, and anxiety. DMVT-501 is a highly potent and selective topical phosphodiesterase-4 inhibitor being evaluated for the treatment of atopic dermatitis.

Learn more at dermavant.com

デルマバント
DMVT-503
にきび
皮膚科
小分子
前臨床

DMVT-503 is an investigational drug candidate with a novel mechanism of action being developed for the topical treatment of acne.

Learn more at dermavant.com

エンザイバント
RVT-801
ファーバー病 (酸性セラミダーゼ欠損症)
まれな病気
生物学の
前臨床

Acid ceramidase deficiency, which manifests as Farber disease, is an ultra-rare lysosomal storage disease caused by a mutation in both alleles of the ASAH1 gene. Like many other lysosomal storage diseases, acid ceramidase deficiency often goes underdiagnosed. Farber patients typically present with the cardinal symptoms of joint contractures or arthritis, subcutaneous nodules, and weak or hoarse voice, which may take years to appear and vary greatly in severity. Patients may also present with systemic inflammation (fever), severe pain, peripheral osteolysis, failure to thrive, and developmental delay.

Recombinant human acid ceramidase (rhAC) is an enzyme replacement therapy (ERT) under development for the treatment of acid ceramidase deficiency. rhAC has shown positive results in various preclinical studies, and has been granted orphan drug, fast track, and rare pediatric disease designations by the U.S. Food and Drug Administration. Enzyvant is preparing a clinical trial in patients with acid ceramidase deficiency.

Enzyvant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at enzyvant.com

ジーンバント
Additional pan-RNA Programs
遺伝性疾患
いろいろ
RNA治療
前臨床

By developing products in-house and forming partnerships, Genevant is building a diverse pipeline of RNA therapeutics across multiple modalities. Through its proprietary LNP and ligand conjugate delivery platforms, Genevant is able to pursue mRNA, RNAi, and gene editing modalities and select the optimal approach for any given disease.

Learn more at genevant.com

ジーンバント
5 mRNA Programs
希少な疾患
まれな病気
RNA治療
前臨床

Genevant is pursuing the co-development and co-commercialization of five mRNA therapeutic programs for rare diseases with high unmet medical need in collaboration with BioNTech AG. The collaboration combines Genevant’s industry-leading lipid nanoparticle (LNP) delivery technology with BioNTech’s cutting-edge mRNA drug discovery platform. Both companies have established GMP-grade manufacturing capabilities and infrastructure.

Learn more at genevant.com

アルバント
ARU-1801
β-タラセミア
血液学
遺伝子治療
前臨床

ARU-1801 is an investigational gene therapy for sickle cell disease and β-thalassemia. ARU-1801 utilizes proprietary technology intended to increase functioning red blood cells by inserting a modified fetal hemoglobin gene into autologous stem cells through a lentiviral vector. Studies have indicated that sickle cell patients with elevated levels of fetal hemoglobin have fewer vaso-occlusive crises and hospitalizations. 

ARU-1801 was developed in the laboratory of Dr. Punam Malik, Director of the Cincinnati Comprehensive Sickle Cell Center at Cincinnati Children’s. Preliminary clinical data from an ongoing Phase 1/2 study of ARU-1801 in patients with sickle cell disease conducted using a reduced-intensity conditioning (RIC) regimen enabled by the unique properties of modified fetal hemoglobin was presented by Dr. Malik in an oral presentation on Monday, December 3rd, 2018, at the Annual Meeting and Exposition of the American Society of Hematology in San Diego, CA.

Learn more at aruvant.com

スピロバント
SPIRO-2101
嚢胞性線維症
呼吸器疾患
生物学の
前臨床

Cystic fibrosis is a life-threatening, autosomal recessive genetic disease that is characterized by progressive airway infection and inflammation, and, in most individuals, death from respiratory failure. It is caused by mutations of the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) that interfere with mucociliary transport and antibacterial activity in the airways and gut, leading to a buildup of mucus and a susceptibility to airway infections that is ultimately lethal. There is no cure for cystic fibrosis, with an estimated 75,000 patients worldwide.

SPIRO-2101 is an adeno-associated (AAV) viral gene therapy platform that consists of a highly optimized transgene payload, a novel AAV capsid, and an augmenter. By collectively driving the high expression of the functional CFTR proteins in human airway epithelia, SPIRO-2101 has the potential to overcome challenges that have previously limited the clinical viability of gene therapy for cystic fibrosis.

Spirovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at spirovant.com

アルタバント
ALTA-2530
閉塞性気管支炎症候群
呼吸器疾患
生物学の
前臨床

Bronchiolitis obliterans syndrome (BOS) is a severe and progressive inflammatory condition resulting in airflow obstruction and loss of function in the lung. It is a form of chronic rejection that often follows lung transplant and hematopoietic stem cell transplantation and can also be caused by autoimmune diseases and by exposure to certain chemicals. BOS is the leading cause of morbidity and mortality in the pulmonary transplant population. According to the International Society for Heart and Lung Transplantation, an estimated 80 percent of patients who receive a lung transplant develop the condition within 10 years of their transplant. There are currently no approved drugs for the treatment of BOS.

Altavant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at altavant.com

Kinevant
Gimsilumab
COVID-19-関連ARDS
呼吸器疾患
生物学の
第二相試験

COVID-19, an infectious disease caused by SARS-CoV-2, has become a global pandemic. Patients with severe cases of COVID-19 experience severe viral pneumonia that often persists despite a decrease in viral load, and can progress to ARDS and death. When implementing standard of care, including mechanical ventilation, ARDS has an overall mortality rate of 41%.

Roivant is developing gimsilumab, a monoclonal antibody that targets GM-CSF, a pro-inflammatory cytokine found to be up-regulated in COVID-19 patients with or at risk of developing ARDS. Gimsilumab has been tested in numerous non-clinical and two clinical studies for rheumatoid arthritis, including a 4-week Phase 1 study in healthy volunteers conducted by Roivant which completed dosing in February. Gimsilumab has demonstrated a favorable safety and tolerability profile based on data collected to date, with no adverse events reported.

In April 2020, Roivant announced the dosing of the first patient in the BREATHE Phase 2 clinical trial of gimsilumab in COVID-19 patients for the prevention and treatment of ARDS.

For more information, click here.

スピロバント
SPIRO-2102
嚢胞性線維症
呼吸器疾患
生物学の
前臨床

Cystic fibrosis is a life-threatening, autosomal recessive genetic disease that is characterized by progressive airway infection and inflammation, and, in most individuals, death from respiratory failure. It is caused by mutations of the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) that interfere with mucociliary transport and antibacterial activity in the airways and gut, leading to a buildup of mucus and a susceptibility to airway infections that is ultimately lethal. There is no cure for cystic fibrosis, with an estimated 75,000 patients worldwide.

SPIRO-2102 is a lentiviral platform pseudotyped with an envelope protein which has demonstrated superior capability to transduce human airway epithelia from apical surfaces. By integrating into the genome with minimal risk of genotoxicity, SPIRO-2102 has the potential to be a single administration, long-lasting genetic treatment for cystic fibrosis.

Spirovant is a part of Roivant’s strategic alliance with Sumitomo Dainippon Pharma.

Learn more about the alliance at spirovant.com

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ニューヨーク、ニューヨーク
ロイヴァントサイエンス株式会社
151西42丁目15階
ニューヨーク、ニューヨーク
10036 米国
バーゼル、スイス
ロイヴァント サイエンス GmbH
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4051 バーゼル
スイス
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