Vivek Ramaswamy

Founder & CEO

We are focused on rapidly developing innovative medicines through a novel form of industrial organization in R&D.

We aim to improve health by rapidly delivering innovative medicines and technologies to patients.

We do this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology.

In addition to our biopharmaceutical subsidiaries, we also build technology-focused Vants focused on improving the process of developing and commercializing medicines.

FOUNDER AND CEO VIVEK RAMASWAMY AT ROIVANT SCIENCES SECOND ANNUAL PIPELINE DAY
FOUNDER AND CEO VIVEK RAMASWAMY AT ROIVANT SCIENCES SECOND ANNUAL PIPELINE DAY
Pipeline

We have a diverse pipeline of investigational drugs in 14 therapeutic areas across our family of companies.

Company
Compound
Indication
Therapeutic Area
Modality
Phase
Dermavant
Tapinarof
Psoriasis
Dermatology
Small Molecule
Phase 3

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

Sinovant
Lefamulin
Community-Acquired Pneumonia
Infectious Disease
Small Molecule
Phase 3

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

Sinovant
Derazantinib
Intrahepatic Cholangiocarcinoma
Oncology
Small Molecule
Phase 3

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

Sinovant
SNV-003
Delayed Graft Function
Nephrology
Small Molecule
Phase 3

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

Sinovant
SNV-003
Acute Kidney Injury
Nephrology
Small Molecule
Phase 2

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

Sinovant
Lefamulin
ABSSSI
Infectious Disease
Small Molecule
Phase 2

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

Sinovant
Naronapride
Constipation
Gastrointestinal Disease
Small Molecule
Phase 2

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

Aruvant
ARU-1801
Sickle Cell Disease
Hematology
Gene Therapy
Phase 2

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

Axovant
AXO-LENTI-PD
Parkinson's Disease
Neurology
Gene Therapy
Phase 2

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

Cytovant
CVT-DC-01
Acute Myeloid Leukemia
Oncology
Cell Therapy
Phase 2

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

Dermavant
Cerdulatinib
Vitiligo
Dermatology
Topical
Phase 2

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

Dermavant
Tapinarof
Atopic Dermatitis
Dermatology
Topical
Phase 2

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

Immunovant
IMVT-1401
Warm Autoimmune Hemolytic Anemia
Immunology
Biologic
Phase 2

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

Immunovant
IMVT-1401
Myasthenia Gravis
Immunology
Biologic
Phase 2

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

Immunovant
IMVT-1401
Thyroid Eye Disease
Immunology
Biologic
Phase 2

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

Metavant
RVT-1501
Diabetes
Cardiometabolic Disease
Small Molecule
Phase 2

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

Respivant
RVT-1601
IPF with Chronic Cough
Respiratory Disease
Drug-Device Combination
Phase 2

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

Axovant
AXO-AAV-GM1
GM1 Gangliosidosis
Neurology
Gene Therapy
Phase 2

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

Axovant
AXO-AAV-GM2
Tay-Sachs/Sandhoff Disease
Neurology
Gene Therapy
Phase 2

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

Dermavant
DMVT-504
Primary Focal Hyperhidrosis
Dermatology
Small Molecule
Phase 1

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

Dermavant
Cerdulatinib
Atopic Dermatitis
Dermatology
Topical
Phase 1

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

Cytovant
CVT-TCR-01
Oncologic Malignancies
Oncology
Cell Therapeutic
Preclinical

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

Dermavant
DMVT-501
Atopic Dermatitis
Dermatology
Small Molecule
Preclinical

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

Dermavant
DMVT-503
Acne Vulgaris
Dermatology
Small Molecule
Preclinical

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

Genevant
Additional pan-RNA Programs
Genetic Disorders
Various
RNA Therapeutic
Preclinical

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

Genevant
5 mRNA Programs
Rare Diseases
Rare Disease
RNA Therapeutic
Preclinical

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

Aruvant
ARU-1801
β-Thalassemia
Hematology
Gene Therapy
Preclinical

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

Kinevant
Gimsilumab
COVID-19-Associated ARDS
Respiratory Disease
Biologic
Phase 2

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.

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We build our Vants through partnerships with companies and academic institutions that share our commitment to developing new medicines for patients and delivering innovation in healthcare.

Roivant has entered into a strategic alliance with Sumitomo Dainippon Pharma to deliver promising new medicines to patients. Other select partners are listed below.

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Roivant Sciences, Inc.
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