FDA Events for Addex Therapeutics (ADXN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Addex Therapeutics (ADXN).
Over the past two years, Addex Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADX71149. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADX71149 - FDA Regulatory Timeline and Events
ADX71149 is a drug developed by Addex Therapeutics for the following indication: Epilepsy.
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:
- ADX71149
- Announced Date:
- April 17, 2025
- Indication:
- Epilepsy
Announcement
Addex Therapeutics announced today that following the previously announced termination of development of ADX71149 (JNJ-40411813) in epilepsy, its partner Janssen Pharmaceuticals, Inc. (now known as J&J Innovative Medicine) has return all development and commercialization rights to ADX71149 (JNJ-40411813) and the partnership between the two companies has been terminated.
AI Summary
Addex Therapeutics announced that after ending the development of ADX71149 (JNJ-40411813) for epilepsy, its partner Janssen Pharmaceuticals—now known as J&J Innovative Medicine—has returned all development and commercialization rights for the asset back to Addex. This decision terminates the partnership between the two companies regarding ADX71149.
The asset, which has completed three Phase 2 studies, is seen as a high-quality candidate. Addex is excited to regain control over its further development and is now evaluating several promising therapeutic indications for its future use. The company is also in discussions with potential partners to advance the program further. This strategic move positions Addex to explore new opportunities in neurological disorders using the robust data they have accumulated so far.
Read Announcement- Drug:
- ADX71149
- Announced Date:
- July 22, 2024
- Indication:
- Epilepsy
Announcement
Addex Therapeutics announced that its partner Janssen Pharmaceuticals, Inc. (now known as J&J Innovative Medicine) has informed the company that it has discontinued development of ADX71149 (JNJ-40411813) in epilepsy.
AI Summary
Addex Therapeutics announced that its partner, Janssen Pharmaceuticals (now known as J&J Innovative Medicine), has halted the development of ADX71149 (JNJ-40411813) for the treatment of epilepsy. This decision comes after a Phase 2 clinical trial did not meet its primary endpoint, which measured the time for patients to reach their baseline seizure count when ADX71149 was added to their standard epilepsy care.
Despite the discontinuation of the epilepsy program, both companies will continue their partnership while the full data set from the trial is analyzed. Addex remains focused on learning from the study’s findings to decide on the potential future of ADX71149. The long-standing relationship between the partners underscores their commitment to exploring new treatments for neurological disorders.
Read Announcement
Addex Therapeutics FDA Events - Frequently Asked Questions
As of now, Addex Therapeutics (ADXN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Addex Therapeutics (ADXN) has reported FDA regulatory activity for ADX71149.
The most recent FDA-related event for Addex Therapeutics occurred on April 17, 2025, involving ADX71149. The update was categorized as "Provided Update," with the company reporting: "Addex Therapeutics announced today that following the previously announced termination of development of ADX71149 (JNJ-40411813) in epilepsy, its partner Janssen Pharmaceuticals, Inc. (now known as J&J Innovative Medicine) has return all development and commercialization rights to ADX71149 (JNJ-40411813) and the partnership between the two companies has been terminated."
Currently, Addex Therapeutics has one therapy (ADX71149) targeting the following condition: Epilepsy.
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:ADXN) was last updated on 7/9/2025 by MarketBeat.com Staff
