FDA Events for DURECT (DRRX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by DURECT (DRRX).
Over the past two years, DURECT has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
larsucosterol. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
larsucosterol - FDA Regulatory Timeline and Events
larsucosterol is a drug developed by DURECT for the following indication: For the treatment of acute organ injury and certain chronic diseases.
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:
- larsucosterol
- Announced Date:
- January 28, 2025
- Indication:
- For the treatment of acute organ injury and certain chronic diseases.
Announcement
DURECT Corporation announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM Evidence.
AI Summary
DURECT Corporation announced the publication of a peer-reviewed article in NEJM Evidence detailing the AHFIRM trial data. The article, titled “Larsucosterol for the Treatment of Alcohol-Associated Hepatitis,” explains how larsucosterol, an epigenetic modulator, was evaluated in patients with severe alcohol-associated hepatitis in a Phase 2b randomized, double-blind study. The trial involved 307 patients divided among three treatment arms—including two different doses of larsucosterol—against a placebo group receiving standard care. Detailed subgroup analyses and liver biomarker data provided important insights, helping researchers understand larsucosterol’s potential benefits and safety profile. These findings have been instrumental in guiding the design of a forthcoming Phase 3 trial, which will focus on U.S. patients and use 90-day mortality as its primary endpoint. The publication of these results in a respected journal underscores the significance of larsucosterol as a promising treatment option for a challenging condition.
Read Announcement- Drug:
- larsucosterol
- Announced Date:
- September 25, 2024
- Indication:
- For the treatment of acute organ injury and certain chronic diseases.
Announcement
DURECT Corporation today provided details on the design of its upcoming registrational Phase 3 trial which will evaluate larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH).
AI Summary
DURECT Corporation has shared details for its upcoming Phase 3 trial to evaluate larsucosterol for patients suffering from severe alcohol-associated hepatitis (AH). The single, multi-center, randomized, double-blind, placebo-controlled study in the United States is planned to enroll about 200 patients. The trial’s primary endpoint is 90-day survival, with topline results expected within two years of starting the study.
The trial design builds on promising Phase 2b AHFIRM data, where both 30 mg and 90 mg doses of larsucosterol showed nearly a 60% reduction in 90-day mortality among U.S. patients compared to placebo. During a recent Type B meeting with the FDA under Breakthrough Therapy designation, key protocol elements were agreed upon, and the FDA confirmed that a single Phase 3 trial will suffice to support a New Drug Application.
Read Announcement- Drug:
- larsucosterol
- Announced Date:
- May 21, 2024
- Indication:
- For the treatment of acute organ injury and certain chronic diseases.
Announcement
DURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH).
AI Summary
DURECT Corporation announced that the FDA has granted Breakthrough Therapy designation to larsucosterol for treating patients with severe alcohol-associated hepatitis (AH). This designation underscores the potential of larsucosterol as a promising treatment option for a life-threatening condition with high mortality rates and no approved therapies. Encouraging clinical evidence from the Phase 2b AHFIRM trial has supported this decision, highlighting the drug’s possible benefits in enhancing survival and reducing liver inflammation in AH patients.
DURECT is now finalizing the design of a registrational Phase 3 clinical trial to further evaluate the safety and efficacy of larsucosterol. The company is optimistic that this expedited pathway will allow for more focused development and review, potentially bringing a much-needed treatment to patients suffering from severe AH. Future clinical updates will be shared as additional data becomes available.
Read Announcement- Drug:
- larsucosterol
- Announced Date:
- April 30, 2024
- Indication:
- For the treatment of acute organ injury and certain chronic diseases.
Announcement
DURECT Corporation announced acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will discuss data from the Company's Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe alcohol-associated hepatitis (AH).
AI Summary
DURECT Corporation announced that its late-breaking oral presentation has been accepted at the European Association for the Study of the Liver (EASL) Congress 2024, which will be held in Milan, Italy from June 5 to 8, 2024. The presentation will focus on data from the company’s Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol for patients suffering from severe alcohol-associated hepatitis (AH). The trial was designed as a randomized, double-blind study, comparing different treatment arms to assess if larsucosterol could improve patient outcomes in this life-threatening condition. This presentation marks an important milestone for DURECT Corporation, as it showcases promising trial results that could lead to a new treatment option for AH, potentially filling a significant unmet medical need for patients who face limited therapeutic choices.
Read Announcement
DURECT FDA Events - Frequently Asked Questions
As of now, DURECT (DRRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, DURECT (DRRX) has reported FDA regulatory activity for larsucosterol.
The most recent FDA-related event for DURECT occurred on January 28, 2025, involving larsucosterol. The update was categorized as "Publication," with the company reporting: "DURECT Corporation announced the publication of a peer-reviewed article on the AHFIRM trial data in NEJM Evidence."
Currently, DURECT has one therapy (larsucosterol) targeting the following condition: For the treatment of acute organ injury and certain chronic diseases..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:DRRX) was last updated on 7/11/2025 by MarketBeat.com Staff
