This section highlights FDA-related milestones and regulatory updates for drugs developed by Vyome (HIND).
Over the past two years, Vyome has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VT-1953 and VT-1908. 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.
VT-1953 FDA Regulatory Timeline and Events
VT-1953 is a drug developed by Vyome for the following indication: Malignant Fungating Wounds.
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:
- VT-1953
- Announced Date:
- April 22, 2026
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc resented its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for symptoms of Malignant Fungating Wounds (MFW) at the 2026 American Association for Cancer Research (AACR) Annual Meeting in San Diego, on April 21, 2026.
AI Summary
Malignant fungating wounds (MFW) are non-healing wounds that affect about 10% of advanced cancer patients—roughly 65,000 people in the U.S. each year. They cause severe symptoms such as a strong “rotten meat” malodor and pain, which harm quality of life and lead many patients to feel ashamed and socially withdraw. There are currently no FDA‑approved drugs to treat these distressing symptoms.
Vyome Holdings, Inc. presented full Phase 2 investigator‑initiated study results and supporting preclinical data for VT‑1953 at the 2026 AACR Annual Meeting in San Diego on April 21, 2026. The data showed VT‑1953 was effective and well tolerated, and on a key secondary endpoint 70% of VT‑1953–treated patients reported improvement in malodor impact to a score of 3–5 by Day 14 from a baseline of 0, versus 0% in the vehicle arm (P = 0.0256). The findings suggest VT‑1953 could meaningfully reduce malodor and improve patients’ quality of life.
Read Announcement- Drug:
- VT-1953
- Announced Date:
- April 6, 2026
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc. announced that the company will present its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for malodor and other symptoms of Malignant Fungating Wounds ("MFW") at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place on April 17-22, 2026, in San Diego.
AI Summary
Vyome Holdings announced it will present full Phase 2 investigator‑initiated study results and supporting preclinical data for VT‑1953, a topical gel being developed to treat malodor and other symptoms of Malignant Fungating Wounds (MFW). The data were accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, held April 17–22, 2026. The company says the findings strengthen the case for advancing VT‑1953 into pivotal studies.
The presentation (CT208 / 3) is scheduled for April 21, 2026, 9:00 AM–12:00 PM and is titled “Final results from a phase 2 trial testing safety and efficacy of VT‑1953 topical gel in patients with malodorous malignant fungating wound.” Authors listed are Arshit Narang, MBBS; Prashant Prakash Lad, MD; and Shiladitya Sengupta, PhD. Materials will cover clinical outcomes and preclinical evidence on VT‑1953’s efficacy and safety as a potential treatment for distressing MFW symptoms.
Read Announcement- Drug:
- VT-1953
- Announced Date:
- February 2, 2026
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc announced it has successfully funded the budget for its VT-1953 Phase 3 study, which provides the Company sufficient capital to fund the estimated costs to release Phase 3 interim results on the efficacy of its drug focused on symptoms of Malignant Fungating Wounds ("MFW").
AI Summary
Vyome Holdings, Inc. said it has secured funding for the VT-1953 Phase 3 study, giving the company enough capital to cover the estimated costs to report interim Phase 3 efficacy results for its drug targeting symptoms of malignant fungating wounds (MFW). Management chose a minimal-dilution financing path with no attached warrants, which preserves more equity value for current shareholders while providing required cash for the near-term clinical milestone.
The funding gives Vyome sufficient liquidity to complete activities needed to reach and disclose the initial Phase 3 interim readout. With the budget in place, the company can continue patient enrollment and data collection, and the interim results will assess VT-1953’s effect on symptom relief in MFW. The move may strengthen Vyome’s ability to engage partners or investors as it advances the program toward later-stage development.
Read Announcement- Drug:
- VT-1953
- Announced Date:
- December 8, 2025
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc. announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds ("MFW").
AI Summary
Vyome Holdings reported final results from an investigator-initiated Phase 2 proof-of-concept study of VT-1953 topical gel in people with malignant fungating wounds (MFW). VT-1953 met its primary endpoint, producing a highly statistically significant reduction in wound malodor by Day 14 (P = 0.002), with significant improvement versus vehicle by Day 14 (P = 0.0015) and as early as Day 7 (P = 0.015). Secondary outcomes also improved: patient-reported impact of odor on quality of life improved (P = 0.0256), and wound pain decreased significantly (P = 0.002 versus baseline; P = 0.0026 versus vehicle). VT-1953 was well tolerated with no new safety concerns observed.
Based on these positive Phase 2 results, Vyome plans to advance VT-1953 into a pivotal Phase III trial and will engage the FDA to design next steps toward approval. The company positions VT-1953 as a first-in-class immunomodulator for MFW and sees a potential ~$1 billion addressable market while pursuing an efficient pivotal development path.
Read Announcement- Drug:
- VT-1953
- Announced Date:
- September 4, 2025
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc announced the interim results from its investigator-initiated Phase 2 PoC study of VT-1953 topical gel in patients with malignant fungating wounds ("MFW").
AI Summary
Vyome Holdings announced interim results from its investigator-initiated Phase 2 proof-of-concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW). These findings were shared at the American Association for Cancer Research annual meeting and show promising early efficacy.
The study met its primary endpoint, with VT-1953 significantly reducing wound malodor (P<0.001). Patients also reported major pain relief (P<0.001) and improved quality of life (P<0.001) as secondary and exploratory endpoints, respectively. No clinically significant adverse trends were noted during treatment.
VT-1953 works by inhibiting inflammatory drivers and targeting both TLR-MD2 and bacterial DNA gyrase to control symptoms. Prior studies have shown the gel is well tolerated in over 500 patients, underscoring its favorable safety profile.
Co-founder Dr. Shiladitya Sengupta will host a live video conference on September 8 to discuss these interim results and outline the path toward full data release in October 2026.
Read Announcement
VT-1908 FDA Regulatory Events
VT-1908 is a drug developed by Vyome for the following indication: To Treat Uveitis.
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:
- VT-1908
- Announced Date:
- February 18, 2026
- Indication:
- To Treat Uveitis
Announcement
Vyome Holdings, Inc announced the publication of its preclinical data validating the efficacy and safety of VT-1908 as a potential treatment for uveitis in the peer-reviewed Journal of Ophthalmic Inflammation and Infection, a Springer-Nature journal1.
AI Summary
Vyome Holdings, Inc. announced the peer-reviewed publication of preclinical data supporting VT-1908 as a potential treatment for uveitis. In laboratory and animal models, VT-1908 reduced eye inflammation and showed a favorable safety profile, giving early evidence that the drug works as intended. Because these results come from preclinical studies, human trials will still be needed to confirm benefit and safety in patients. Still, the findings strengthen the scientific case for advancing VT-1908 and suggest it could become a future option for treating uveitis, a serious inflammatory eye condition that can cause pain and vision loss.
The data were published in the Journal of Ophthalmic Inflammation and Infection, a Springer-Nature peer-reviewed journal, providing independent review and wider visibility for Vyome’s research.
Read Announcement- Drug:
- VT-1908
- Announced Date:
- September 17, 2025
- Indication:
- To Treat Uveitis
Announcement
Vyome Holdings, Inc presented results from its preclinical studies investigating VT-1908 (the first topical formulation of mycophenolate) for treating uveitis at the recent Annual Meeting of the American Society for Pharmacology and Experimental Therapeutics (1).
AI Summary
At the recent Annual Meeting of the American Society for Pharmacology and Experimental Therapeutics, Vyome Holdings, Inc. presented preclinical results for VT-1908, the first topical formulation of mycophenolate designed to treat uveitis. In a model of anterior uveitis, twice-daily VT-1908 eye drops achieved the desired drug concentration in the front chamber of the eye and significantly lowered the uveitis score (P<0.001). Testing showed VT-1908 matched the effectiveness of a standard steroid but without risks like cataracts or increased eye pressure.
Dr. Shiladitya Sengupta, Vyome’s co-founder, said VT-1908 could replace steroids and help patients who cannot use them. CEO Venkat Nelabhotla added that Vyome plans to start a Phase 1/2 clinical trial in the second half of 2026. While uveitis is the initial focus, the company aims to address the broader $20 billion ocular inflammation market.
Read Announcement
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