This section highlights FDA-related milestones and regulatory updates for drugs developed by VYNE Therapeutics (VYNE).
Over the past two years, VYNE Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VYN201 and VYN202. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VYN201 - FDA Regulatory Timeline and Events
VYN201 is a drug developed by VYNE Therapeutics for the following indication: Vitiligo.
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:
- VYN201
- Announced Date:
- March 6, 2025
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics provided a business update.
AI Summary
VYNE Therapeutics recently provided a business update highlighting significant progress and upcoming milestones for its clinical trials in 2025. The company announced that its Phase 2b trial for repibresib gel (VYN201), a locally administered pan-BD BET inhibitor for nonsegmental vitiligo, has completed enrollment. Topline results from this trial are expected in mid-2025. In addition, VYNE initiated a Phase 1b trial for VYN202, an oral BD2-selective inhibitor targeting moderate-to-severe plaque psoriasis, with topline findings anticipated by the end of 2025.
CEO David Domzalski emphasized that these developments are part of a strong start to 2025. He noted that the company’s financial resources are secure, providing a cash runway into the second half of 2026, which supports ongoing efforts to address high unmet needs in chronic inflammatory and immune-mediated conditions.
Read Announcement- Drug:
- VYN201
- Announced Date:
- January 6, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics Inc. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.
AI Summary
VYNE Therapeutics Inc. has completed enrollment in its Phase 2b trial to evaluate the safety and effectiveness of once-daily repibresib gel for treating nonsegmental vitiligo. This double-blind, vehicle-controlled study compares three dose cohorts (1%, 2%, and 3%) against a placebo over a 24-week period. The primary goal is to determine how many participants reach a significant improvement in facial vitiligo, with additional measures planned to assess overall benefits.
Top-line data from this 24-week trial segment is expected to be announced in mid-2025. The new non-proprietary name for repibresib, adopted by the USAN Council, supports the continued advancement of this differentiated therapy. VYNE’s progress in this trial marks an important step towards providing a new treatment option for patients with vitiligo.
Read Announcement- Drug:
- VYN201
- Announced Date:
- January 6, 2025
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics Inc. announced completion of enrollment in the Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo.
AI Summary
VYNE Therapeutics Inc. announced that it has completed enrollment in a Phase 2b clinical trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. The trial is a randomized, double-blind, vehicle-controlled study designed to assess the safety, pharmacokinetics, and efficacy of once-daily VYN201 gel, which contains the new chemical entity repibresib. Participants are being treated across three dose levels (1%, 2%, and 3%) over 24 weeks, with additional treatment available for up to 28 weeks after the initial period.
Top-line data from the 24-week treatment phase are expected in mid-2025. The completion of enrollment is seen as a significant milestone by VYNE, reinforcing the company’s progress in developing a differentiated therapy for nonsegmental vitiligo, a condition that currently has few treatment options. The trial aims to provide valuable insights into how effective this new therapy can be for patients.
Read Announcement- Drug:
- VYN201
- Announced Date:
- June 5, 2024
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics Inc. announced that the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration.
AI Summary
VYNE Therapeutics Inc. recently announced that the first subject has been dosed in its Phase 2b trial for VYN201, a novel pan-bromodomain and extra-terminal (BET) inhibitor. VYN201 is designed for local application as a topical gel and will be tested in subjects with either active or stable nonsegmental vitiligo. The trial will evaluate once-daily dosing in three concentrations: 1%, 2%, and 3% over a 24‑week period. Researchers aim to see if VYN201 can improve facial pigmentation by at least 50%, a key measure of its efficacy, with extended treatment planned for an additional 28 weeks. This milestone marks an important step toward developing a new treatment option for vitiligo patients. The top-line data from the trial is expected in mid‑2025, and the company is optimistic based on earlier positive findings related to safety, tolerability, and clinical response.
Read Announcement- Drug:
- VYN201
- Announced Date:
- June 5, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics Inc. announced that Top-line data from the 24-week double-blind portion of the trial expected in mid-2025
AI Summary
VYNE Therapeutics Inc. has initiated a Phase 2b clinical trial to evaluate its once-daily VYN201 gel in patients with either active or stable nonsegmental vitiligo. This trial is randomized, double-blind, and vehicle-controlled, and it will test three concentrations (1%, 2%, and 3%) of the topical gel. Approximately 160 subjects will be enrolled, and the trial will be conducted over a 24-week treatment window. VYNE plans to collect and assess top-line data from this double-blind portion of the study, with results expected to be reported in mid-2025. The study aims to measure safety and efficacy, with one of the main goals being the improvement in facial vitiligo severity. This milestone marks a critical step in advancing VYN201 as a promising new therapy for vitiligo patients.
Read Announcement- Drug:
- VYN201
- Announced Date:
- May 1, 2024
- Indication:
- Vitiligo
Announcement
VYNE Therapeutics Inc. announced two abstracts reporting results for its novel BET inhibitor, VYN201, have been selected for presentation at the 81st Annual Meeting of the Society for Investigative Dermatology (SID), being held May 15-18, 2024 in Dallas, TX, USA.
AI Summary
VYNE Therapeutics Inc. announced that its latest research on the BET inhibitor VYN201 has been chosen for presentation at the 81st Annual Meeting of the Society for Investigative Dermatology in Dallas, TX, from May 15-18, 2024. Two abstracts will be presented at the meeting. One presentation, scheduled for May 16, will cover promising preclinical studies, while another on May 18 will discuss the Phase 1b trial results in patients with nonsegmental vitiligo. The data reveal positive outcomes such as a rapid onset of action and a dose-dependent improvement in the condition. These promising results support the potential of VYN201 as a differentiated therapy for nonsegmental vitiligo. VYNE’s team is looking forward to sharing and discussing these findings with researchers and clinicians at this influential dermatology event.
Read Announcement
VYN202 - FDA Regulatory Timeline and Events
VYN202 is a drug developed by VYNE Therapeutics for the following indication: A Novel BD2-Selective BET Inhibitor.
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:
- VYN202
- Announced Date:
- July 2, 2025
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc today provided a program update for VYN202 following the clinical hold issued by the U.S. Food and Drug Administration (FDA) in April for the Company's Phase 1b clinical trial in the treatment of moderate-to-severe plaque psoriasis.
AI Summary
VYNE Therapeutics Inc. provided an update on its VYN202 program, an oral small molecule BET inhibitor for treating moderate-to-severe plaque psoriasis. The FDA had placed a clinical hold on the Phase 1b trial in April due to testicular toxicity observed in dogs during non-clinical studies. The hold has now been partially lifted, allowing female patients to continue receiving the lower doses of 0.25 mg and 0.5 mg, while the 1 mg dose is suspended because of its lower toxicological safety margin. For male patients, the trial remains on hold until additional data from a 12-week toxicology study in dogs is provided and reviewed. In response, the Company has unblinded the data from the ongoing trial and has decided to stop enrolling additional psoriasis patients as it refocuses VYN202’s development towards other serious immune-mediated diseases.
Read Announcement- Drug:
- VYN202
- Announced Date:
- April 25, 2025
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company's Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis.
AI Summary
VYNE Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) verbally informed the company of a clinical hold on its Phase 1b study. This study was evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The action came after the FDA observed testicular toxicity in dogs during a non-clinical toxicology study involving VYN202.
As a result, all patient screening, enrollment, and dosing in the Phase 1b trial have been suspended. VYNE stressed that no serious adverse events have been reported among enrolled subjects so far. The company is committed to working closely with the FDA to resolve the clinical hold as quickly as possible, underscoring its dedication to patient safety and the responsible development of its therapeutic candidate.
Read Announcement - Drug:
- VYN202
- Announced Date:
- February 19, 2025
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc. announced that the first subject has been dosed in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis.
AI Summary
VYNE Therapeutics Inc. announced that the first subject has been dosed in a Phase 1b trial evaluating VYN202, an innovative oral small molecule BET inhibitor, for the treatment of moderate-to-severe plaque psoriasis. This 12‐week, randomized, double-blind, placebo-controlled trial will primarily test the safety of once-daily VYN202. In addition, the study will assess the drug’s pharmacokinetics and gather early evidence of its efficacy through improvements in psoriasis severity, as measured by PASI scores.
Top-line data from this trial are expected by the end of 2025. Building on encouraging results from earlier Phase 1a studies, the trial may provide key insights into the potential of VYN202 as a convenient, novel treatment option not only for psoriasis but also for other chronic, immune-mediated conditions.
Read Announcement- Drug:
- VYN202
- Announced Date:
- December 23, 2024
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc announced positive results from the multiple ascending dose ("MAD") portion of its Phase 1a SAD/MAD trial of VYN202.
AI Summary
VYNE Therapeutics Inc. announced positive results from the multiple ascending dose (MAD) portion of its Phase 1a SAD/MAD trial of VYN202. In this trial, healthy volunteers received daily doses of VYN202 for 14 days. The data showed that VYN202 has a good safety profile with no serious or drug-related adverse events, eliminating issues like thrombocytopenia seen with earlier BET inhibitors. The drug reached steady-state levels after seven doses and maintained effective blood concentrations throughout a 24-hour period, supporting its once-daily dosing. It also demonstrated robust effects by engaging its target marker and significantly reducing inflammatory biomarkers associated with immune-mediated disorders. These promising results suggest that VYN202 may offer a new, convenient treatment option for various immune and inflammatory conditions, paving the way for further clinical trials to assess its long-term benefits.
Read Announcement- Drug:
- VYN202
- Announced Date:
- September 12, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc. announced that Dosing has begun in the MAD portion of the trial with results expected in Q4 2024
AI Summary
VYNE Therapeutics Inc. recently announced that they have begun dosing in the multiple ascending dose (MAD) portion of their Phase 1a clinical trial for VYN202. This part of the trial will assess the safety, tolerability, and drug behavior over a period of 14 days using different dose levels. Researchers will continue to monitor the pharmacokinetics and pharmacodynamics of VYN202, with a focus on its impact on key inflammatory biomarkers. The company expects to share the trial results in the fourth quarter of 2024. These findings will help determine how VYN202 interacts in the body after multiple doses and will guide further studies in treating conditions such as psoriasis and rheumatoid arthritis.
Read Announcement- Drug:
- VYN202
- Announced Date:
- September 12, 2024
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc. announced positive data from the single ascending dose ("SAD") portion of its ongoing Phase 1a trial of VYN202.
AI Summary
VYNE Therapeutics Inc. announced positive results from the single ascending dose (SAD) portion of its ongoing Phase 1a trial for VYN202. In this study, VYN202 was found to be generally well tolerated in healthy volunteers, with no drug-related adverse events reported across all dose groups. The pharmacokinetic data showed that VYN202’s exposure in blood increased in a dose-dependent manner, meeting expectations for plasma and urine concentrations. Additionally, the pharmacodynamic activity was promising, as blood tests revealed increased levels of the marker protein HEXIM1, indicating successful target engagement with BET proteins, and showed an inhibitory effect on certain inflammatory biomarkers related to conditions like psoriasis and rheumatoid arthritis. The trial has now progressed to the multiple ascending dose (MAD) portion, with further results anticipated in Q4 2024.
Read Announcement- Drug:
- VYN202
- Announced Date:
- July 16, 2024
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc. announced GB Patent No. 2621505 entitled "Pyrrolopyridone derivatives useful in the treatment of inflammatory disorders, immune disorders and cancer" has been granted by the United Kingdom's Intellectual Property Office.
AI Summary
VYNE Therapeutics Inc. announced that the United Kingdom’s Intellectual Property Office has granted GB Patent No. 2621505 for “Pyrrolopyridone derivatives useful in the treatment of inflammatory disorders, immune disorders and cancer.” This patent covers the compound within the company’s VYN202 program and provides intellectual property protection for 20 years until June 2042. The patent is a crucial milestone for VYNE as it helps secure exclusive rights to this new chemical entity, reinforcing the potential of VYN202 as one of the most potent and BD2-selective BET inhibitors in development.
Company leadership emphasized that securing patents is a key value driver, and VYNE plans to pursue additional protection in other jurisdictions. By strengthening its patent portfolio, VYNE is well-positioned to advance its pipeline and offer innovative treatment options for patients suffering from inflammatory and immune-related conditions.
Read Announcement- Drug:
- VYN202
- Announced Date:
- May 6, 2024
- Indication:
- A Novel BD2-Selective BET Inhibitor
Announcement
VYNE Therapeutics Inc announced the clearance of its Investigational New Drug application ("IND") by the U.S. Food and Drug Administration for VYN202, an oral BD2-selective BET inhibitor.
AI Summary
VYNE Therapeutics Inc. has received clearance from the U.S. Food and Drug Administration to move forward with its Investigational New Drug application for VYN202, an oral BD2-selective BET inhibitor. This clearance marks a significant milestone for the company as it works on a promising therapy to treat autoimmune diseases and other immuno-inflammatory conditions. The drug is designed to block parts of the inflammatory process by targeting BET proteins, which are involved in gene transcription related to immune cell activation.
VYNE plans to start a Phase 1a clinical trial in healthy volunteers this quarter, using both single ascending dose (SAD) and multiple ascending dose (MAD) approaches. The trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202, with top-line results expected later this year. This advancement paves the way for future studies in patients with chronic inflammatory diseases.
Read Announcement
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