This section highlights FDA-related milestones and regulatory updates for drugs developed by Dermata Therapeutics (DRMAW).
Over the past two years, Dermata Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DMT310 and XYNGARI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DMT310 - FDA Regulatory Timeline and Events
DMT310 is a drug developed by Dermata Therapeutics for the following indication: For the treatment of acne.
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:
- DMT310
- Announced Date:
- December 16, 2024
- Indication:
- For the treatment of acne
Announcement
Dermata Therapeutics, y announced that it received approval from U.S. Food and Drug Administration (FDA) of the proprietary name, Xyngari (pronounced zin-gar-ee) (formerly DMT310), for its Phase 3 clinical drug candidate in acne.
AI Summary
Dermata Therapeutics announced that the FDA has approved the proprietary name Xyngari (formerly DMT310) for its Phase 3 clinical drug candidate for treating acne. The approval of the name is a significant step in the company’s development program as it prepares to file a new drug application (NDA) pending successful trial outcomes.
Xyngari, a once-weekly topical treatment under study, is being evaluated in a Phase 3 clinical trial with topline results from the STAR-1 study expected in March 2025. The company believes that having this approved name, along with recent patent news, positions it well for the NDA filing and eventual market entry. Dermata is optimistic that Xyngari could become a safe, effective option for patients struggling with moderate-to-severe acne.
Read Announcement- Drug:
- DMT310
- Announced Date:
- July 17, 2024
- Indication:
- For the treatment of acne
Announcement
Dermata Therapeutics, Inc. announced that it has successfully enrolled 50% of patients in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study of DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
AI Summary
Dermata Therapeutics, Inc. recently announced that it has successfully enrolled 50% of patients in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study. The study is evaluating DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. If approved, DMT310 could become the first treatment of its kind, offering a new once-weekly option for acne sufferers. Enrollment began in December 2023, and with all clinical sites active in the United States and Latin America, the company expects significant enrollment progress leading to topline results in the first quarter of 2025. Investigators are enthusiastic about DMT310 and its potential benefits, highlighting the need for safe, effective acne treatments and reinforcing Dermata’s commitment to advancing innovative skin care solutions.
Read Announcement
XYNGARI - FDA Regulatory Timeline and Events
XYNGARI is a drug developed by Dermata Therapeutics for the following indication: Spongilla Treatment for Acne.
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:
- XYNGARI
- Announced Date:
- March 27, 2025
- Indication:
- Spongilla Treatment for Acne
Announcement
Dermata Therapeutics, Inc. announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
AI Summary
Dermata Therapeutics, Inc. announced positive topline results from its first pivotal Phase 3 trial of XYNGARI™, a novel, once‐weekly topical product designed to treat moderate-to-severe acne. The study, known as STAR-1, involved 520 patients and met all three primary endpoints. Patients experienced a statistically significant improvement in both inflammatory and non-inflammatory acne lesions, as well as a notable improvement on the Investigator Global Assessment scale.
The trial results also showed that XYNGARI™ was safe and well tolerated with minimal treatment-related adverse events. With over 30 million acne patients seeking treatment annually in the U.S., a once-weekly regimen like XYNGARI™ could offer a unique treatment option that may improve patient compliance compared to products applied daily. These promising results support further development and the upcoming Phase 3 STAR-2 trial later in 2025.
Read Announcement- Drug:
- XYNGARI
- Announced Date:
- March 4, 2025
- Indication:
- Spongilla Treatment for Acne
Announcement
Dermata Therapeutics, Inc. announced that the last patient has completed their last visit in the Company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
AI Summary
Dermata Therapeutics, Inc. announced that the last patient in its important Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial has completed their final visit. This trial tested XYNGARI™, a novel once-weekly, topical treatment candidate for moderate-to-severe acne. A total of 520 patients in the United States and Latin America took part in this study, which aimed to show the product’s effectiveness in reducing both inflammatory and noninflammatory acne lesions. With this milestone reached, the company is now focused on locking the trial data and preparing to announce topline results by the end of March 2025. Dermata Therapeutics believes that XYNGARI™ could provide a more convenient and effective alternative to traditional acne treatments, potentially changing the standard of care for millions of acne patients.Read Announcement
- Drug:
- XYNGARI
- Announced Date:
- March 4, 2025
- Estimated Event Date Range:
- March 1, 2025 - March 31, 2025
- Target Action Date:
- March 1, 2025
- Indication:
- Spongilla Treatment for Acne
Announcement
Dermata Therapeutics, Inc announced The Company remains on track to announce topline data by the end of March 2025..
AI Summary
Dermata Therapeutics, Inc. announced that the final patient in its Phase 3 STAR-1 trial for XYNGARI™ has completed their last visit. The study, which enrolled 520 patients with moderate-to-severe acne from the U.S. and Latin America, is designed to evaluate the efficacy, safety, and tolerability of this once-weekly, topical product candidate. With the last patient visit behind them, the company is now focused on finalizing the database in preparation for the upcoming data review.
Dermata remains on track to announce topline results by the end of March 2025. The company believes these results could offer a new, convenient alternative for acne treatment by addressing multiple root causes of the condition. This milestone is an important step in the ongoing development of XYNGARI™, which aims to change current acne treatment options if approved by the FDA.
Read Announcement
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