Developer · NEUP · Australia
Neuphoria Therapeutics, Inc.
Neuphoria Therapeutics is a clinical-stage biopharmaceutical company developing allosteric ion-channel modulators for central nervous system disorders. Formerly the Australian company Bionomics Limited, it redomiciled to the United States and renamed to Neuphoria Therapeutics, Inc. on December 24, 2024; its lead asset is BNC210 (soclenicant), an oral, selective negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor that was developed for social anxiety disorder and PTSD.
Pipeline (1)
- Post-traumatic stress disorderPhase 2Suspended
- Social anxiety disorderDiscontinuedDiscontinued
Catalysts · 0 upcoming · 3 reported
Recently reported
- 2025-10-20missed
BNC210 (soclenicant)forSocial anxiety disorderTopline data
Phase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program.
- 2024-12-09met
BNC210 (soclenicant)forPost-traumatic stress disorderFull results
ATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged.
- 2023-09-29met
BNC210 (soclenicant)forPost-traumatic stress disorderTopline data
Phase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048).
Recent activity
- Oct 20, 2025ReadoutBNC210 (soclenicant)·Social anxiety disordermissedPhase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program.source ↗
- Sep 11, 2025Phase changeBNC210 (soclenicant)·Social anxiety disorderPhase 3AFFIRM-1 reaches primary completion (11 Sep 2025); 370 participants enrolled (actual). Trial record marked Completed on ClinicalTrials.gov.source ↗
- Dec 9, 2024ReadoutBNC210 (soclenicant)·Post-traumatic stress disordermetATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged.source ↗
- Aug 6, 2024Phase changeBNC210 (soclenicant)·Social anxiety disorderPhase 3Phase 3 AFFIRM-1 (NCT06510504) in social anxiety disorder begins (study start 6 Aug 2024). Randomized, double-blind, placebo-controlled, single acute as-needed dose of 225 mg BNC210 vs placebo evaluated in a public speaking challenge model; primary endpoint = change from baseline in average performance-phase SUDS. Lead sponsor Bionomics Limited (Neuphoria Therapeutics).source ↗
- Jul 31, 2024Phase changeBNC210 (soclenicant)·Post-traumatic stress disorderPhase 2Successful FDA End-of-Phase-2 meeting (held 26 Jun 2024): FDA supported a path to NDA for PTSD with a single Phase 3 trial (900 mg and 600 mg BID, 12-week double-blind + 52-week open-label extension, CAPS-5 primary). BNC210 holds FDA Fast Track designation for PTSD.source ↗
- Sep 29, 2023ReadoutBNC210 (soclenicant)·Post-traumatic stress disordermetPhase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048).source ↗
Competitive landscape
Other companies developing against Neuphoria Therapeutics, Inc.'s targets or indications.
- Vanda Pharmaceuticals Inc.1 compoundalpha7 nAChRSocial anxiety disorder
- COMPASS Pathways plc1 compoundPost-traumatic stress disorder
- Definium Therapeutics, Inc.1 compoundPost-traumatic stress disorder
- EmpathBio, Inc.1 compoundSocial anxiety disorder
- Hoffmann-La Roche1 compoundSocial anxiety disorder
- Merck & Co., Inc.1 compoundalpha7 nAChR
- Otsuka Pharmaceutical Co., Ltd.1 compoundPost-traumatic stress disorder
- Tonix Pharmaceuticals Holding Corp.1 compoundPost-traumatic stress disorder
- Transcend Therapeutics, Inc.1 compoundPost-traumatic stress disorder
- Vistagen Therapeutics, Inc.1 compoundSocial anxiety disorder
