Addex Therapeutics (ADXN) has upcoming FDA regulatory milestones for NTX-253. The table below outlines estimated target dates and event types for these pending regulatory actions.
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
NTX-253 and ADX71149. 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.
NTX-253 FDA Regulatory Timeline and Events
NTX-253 is a drug developed by Addex Therapeutics for the following indication: for Schizophrenia.
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:
- NTX-253
- Announced Date:
- April 23, 2026
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- for Schizophrenia
Announcement
Addex Therapeutics announced that its spin-out company, Neurosterix, is on track to complete its Phase 1 clinical study evaluating NTX-253 in Q2 2026.
AI Summary
Addex Therapeutics said its spin-out, Neurosterix, is on track to complete a Phase 1 clinical study of NTX-253 in Q2 2026. The trial uses a multi-part, ascending-dose design to quickly define the drug’s clinical profile and support later patient studies. It includes single ascending dose (SAD) and multiple ascending dose (MAD) parts, plus translational assessments like food-effect and cerebrospinal fluid (CSF) sampling to better understand how NTX-253 behaves in the body.
The MAD phase gives participants once-daily oral NTX-253 or placebo for 10 days with dose escalation to assess safety, tolerability, and steady-state pharmacokinetics. Two MAD cohorts include adults with stable schizophrenia who will have antipsychotic medications withdrawn for up to eight days to permit testing while keeping them clinically stable. Neurosterix was spun out in April 2024 with $65 million in Series A funding, and Addex retains a 20% equity stake. NTX-253 is being developed as an M4 positive allosteric modulator (PAM).
Read Announcement- Drug:
- NTX-253
- Announced Date:
- January 7, 2026
- Indication:
- for Schizophrenia
Announcement
Addex Therapeutics announced that its spin-out company, Neurosterix, has started a Phase 1 clinical study of NTX-253. NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor being developed for the treatment of schizophrenia.
AI Summary
Addex Therapeutics’ spin-out, Neurosterix, has begun a Phase 1 clinical study of NTX-253, a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor. The first-in-human study will test safety, tolerability, pharmacokinetics (how the drug is processed in the body) and pharmacodynamics (how the drug affects the body) in healthy volunteers. NTX-253 is being developed as a potential treatment for schizophrenia.
NTX-253 and other M4 PAMs aim to reduce psychosis by indirectly modulating dopamine signaling, which could avoid the motor and metabolic side effects linked to traditional dopamine-blocking antipsychotics. Preclinical studies showed strong antipsychotic-like effects and a favorable safety profile, supporting the move to human testing. Neurosterix was spun out of Addex in 2024; Addex retains a 20% equity interest in the company. The Phase 1 readout will guide further clinical development decisions.
Read Announcement
ADX71149 FDA Regulatory 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
