This section highlights FDA-related milestones and regulatory updates for drugs developed by Roivant Sciences (ROIV).
Over the past two years, Roivant Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Brepocitinib, Mosliciguat, and VTAMA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Brepocitinib FDA Regulatory Events
Brepocitinib is a drug developed by Roivant Sciences for the following indication: Systemic Lupus Erythematosus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Brepocitinib
- Announced Date:
- September 17, 2025
- Indication:
- Systemic Lupus Erythematosus
Announcement
Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).
AI Summary
Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). Once-daily oral brepocitinib 30 mg showed clinically meaningful and statistically significant improvement versus placebo on the primary endpoint and all nine key secondary endpoints, including measures of skin and muscle disease, steroid-sparing effect, and rapid onset of action. At week 52, the mean Total Improvement Score (TIS) was 46.5 for brepocitinib 30 mg compared to 31.2 for placebo (p=0.0006), even though nearly twice as many patients on brepocitinib discontinued background steroids. More than two-thirds of patients achieved at least a moderate response (TIS ≥ 40), and nearly half experienced a major response (TIS ≥ 60).
A clear dose-response between the 30 mg and 15 mg arms established 30 mg as the optimal dose, and the safety profile was consistent with earlier trials. Brepocitinib demonstrated significant separation from placebo as early as week 4 and maintained benefits through one year. An NDA filing is planned for the first half of 2026, marking a potential breakthrough as the first positive 52-week placebo-controlled trial of a targeted therapy in DM.
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Mosliciguat FDA Regulatory Events
Mosliciguat is a drug developed by Roivant Sciences for the following indication: In PH patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Mosliciguat
- Announced Date:
- September 4, 2025
- Indication:
- In PH patients.
Announcement
Roivant announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator, currently being studied for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), which is a progressive and life-threatening condition with significant unmet medical need.
AI Summary
Roivant announced that Japan’s Ministry of Health, Labour and Welfare has granted orphan drug designation (ODD) to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase activator. Mosliciguat is being studied for Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), a progressive, life-threatening condition with no approved treatments.
The ODD status, based on the recommendation of Japan’s Pharmaceuticals and Medical Devices Agency, provides key regulatory incentives such as priority consultation, reduced fees, and up to ten years of market exclusivity if approved. Roivant’s CEO Drew Fromkin said this designation recognizes the significant unmet need for PH-ILD patients and underscores the company’s commitment to advancing mosliciguat in Japan.
Mosliciguat is now in a global Phase 2 trial called PHocus, which will enroll about 120 adults with PH-ILD. Details of the study design will be presented in a poster at the European Respiratory Society International Congress on September 28, 2025.
Read Announcement- Drug:
- Mosliciguat
- Announced Date:
- September 10, 2024
- Indication:
- In PH patients.
Announcement
Pulmovant, a Roivant company announced the presentation of data from the proof-of-concept Phase 1b ATMOS1 study during the ERS Congress in Vienna, Austria.
AI Summary
Pulmovant, a Roivant company, recently presented data from its proof-of-concept Phase 1b ATMOS1 study during the European Respiratory Society (ERS) Congress in Vienna, Austria. The study evaluated mosliciguat, an innovative, first-in-class inhaled soluble Guanylate Cyclase (sGC) activator specifically designed to target the lungs in patients with pulmonary hypertension (PH).
In this trial, 38 patients received a single dose of mosliciguat via a dry powder inhaler, resulting in a sustained, clinically meaningful reduction of pulmonary vascular resistance (PVR) by up to 38%—one of the most significant drops seen in PH studies. The once-daily dosing was well tolerated, with few treatment-emergent adverse events reported. These promising findings have set the stage for further research, including an upcoming global Phase 2 study focused on patients with PH associated with interstitial lung disease (PH-ILD).
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VTAMA (tapinarof) cream FDA Regulatory Events
VTAMA (tapinarof) cream is a drug developed by Roivant Sciences for the following indication: Plaque psoriasis.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- December 16, 2024
- Indication:
- Plaque psoriasis
Announcement
Organon announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1
AI Summary
Organon announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1% for an additional indication. This new approval expands its use to treat atopic dermatitis (AD) in adults and pediatric patients aged 2 years and older. VTAMA cream is an aryl hydrocarbon receptor agonist that has shown strong results in clinical studies, with many patients achieving clear or almost clear skin within 8 weeks. Patients also experienced rapid itch relief, with improvements noted as early as 24 hours after the first application. The cream has demonstrated a favorable and consistent safety profile, with no warnings, precautions, or restrictions regarding the duration of use or treated body surface area. This approval represents a promising new treatment option for those suffering from atopic dermatitis, addressing a significant unmet need among both adults and children.
Read Announcement- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- December 16, 2024
- Estimated Event Date Range:
- March 12, 2025 - March 12, 2025
- Target Action Date:
- March 12, 2025
- Indication:
- Plaque psoriasis
Announcement
Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.
AI Summary
Organon announced that the FDA approved VTAMA® (tapinarof) cream, 1%, for the topical treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. Notably, Organon received this approval before the extended target action date (PDUFA) of March 12, 2025. This early approval underscores the FDA’s confidence in VTAMA’s safety and efficacy profile.
The new approval offers an additional treatment option for patients with atopic dermatitis by providing a therapy that can lead to powerful skin clearance and fast itch relief. VTAMA cream has shown positive results in pivotal studies, and its approval means that professionals can now prescribe a non-steroidal treatment without restrictions on duration of use or affected body surface area. This marks a significant advancement in the treatment of atopic dermatitis for both children and adults.
Read Announcement
