BNC210 · program

BNC210 (soclenicant) for Post-traumatic stress disorder

Phase 2SuspendedNeuphoria Therapeutics, Inc. (NEUP)
  • Fast Track

Indications for BNC210: Social anxiety disorder · Discontinued Post-traumatic stress disorder · Phase 2

Oral alpha7-nAChR NAM for PTSD. The Phase 2b ATTUNE study (NCT04951076; 900 mg BID vs placebo, 12 weeks, n=212 randomized / mITT 182) MET its primary CAPS-5 endpoint at Week 12 (LS mean difference -4.03, Cohen's d 0.40, p=0.048), with significant benefit on depression (MADRS, p=0.040) and sleep (ISI); results published in NEJM Evidence (Jan 2025, DOI 10.1056/EVIDoa2400380). BNC210 holds FDA Fast Track designation for PTSD, and a 26 Jun 2024 End-of-Phase-2 meeting endorsed a single confirmatory Phase 3 (900 mg and 600 mg BID, 12-week double-blind + 52-week open-label extension, CAPS-5 primary) as a path to NDA. However, that Phase 3 PTSD trial was never initiated: after the company's SEPARATE Phase 3 AFFIRM-1 trial in social anxiety disorder MISSED its primary and secondary endpoints (20 Oct 2025), Bionomics/Neuphoria discontinued the SAD program and PAUSED the BNC210 PTSD program, terminated nearly all employees, and entered a strategic review. PTSD development remains paused (not discontinued) as of mid-2026.

Data current as of

Development timeline

Phase 2Sept 2023 – Oct 2025
  1. mixedPhase 3 PTSD trial (planned 2H 2025) never started; PTSD program paused after the SAD Phase 3 failure.↗
  2. metATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged.↗
  3. Successful 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.↗
  4. metPhase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048).↗

Readouts

  • 2H 2025CancelledRegulatorymixed

    Phase 3 PTSD trial (planned 2H 2025) never started; PTSD program paused after the SAD Phase 3 failure. ↗

  • 2024-12-09ReportedFull resultsmetNCT04951076

    ATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged. ↗

  • 2023-09-29ReportedTopline datametNCT04951076

    Phase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048). ↗

Clinical trials in Post-traumatic stress disorder

NCT04951076ATTUNEPhase 2Completedn=212

A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)

Started Jul 2021· Primary completion Jul 2023· 📍 32 sites across 2 countries (United States, United Kingdom)

metprimaryCAPS-5 total symptom severity, change from baseline to Week 12 — LS mean difference -4.03 (Cohen's d 0.40) (0.048)

BNC210 900 mg BID improved CAPS-5 vs placebo at Week 12 (mITT n=182), with separation as early as Week 4. Primary endpoint met.

metsecondaryMADRS depressive symptoms, change from baseline to Week 12 — LS mean difference -3.19 (0.040)

Statistically significant improvement in depressive symptoms (MADRS); meaningful improvement in sleep (ISI) also reported.

mixedsafetySafety / tolerability (treatment-emergent adverse events)

TEAEs in 66.7% (BNC210) vs 53.8% (placebo); most common headache, nausea, fatigue and hepatic enzyme elevations. 21 BNC210 vs 10 placebo discontinued for AEs; no serious AEs or deaths in the BNC210 group.

Mechanism of action (compound-wide)

Selective negative allosteric modulator (NAM) of the alpha-7 nicotinic acetylcholine receptor (alpha7 nAChR; CHRNA7), partially inhibiting alpha7 channel activation while sparing alpha4beta2 nAChR signalling. By dampening alpha7-mediated cholinergic tone in fear/stress circuitry it produces anxiolytic and PTSD-symptom-reducing effects without sedation or dependence. No quantitative binding/inhibitory constant for the NAM action is published in IUPHAR/GtoPdb or ChEMBL.

TargetActionAffinity
alpha7 nAChRprimaryCHRNA7NAM—ⓘ

← Full BNC210 compound page (identity, identifiers, all indications)

Sources

  1. ATTUNE: Phase 2b study of BNC210 vs placebo in PTSD (NCT04951076) — ClinicalTrials.gov
  2. Bionomics announces positive topline results from the Phase 2b ATTUNE trial of BNC210 in PTSD — Bionomics Limited (PR Newswire)
  3. Bionomics announces successful End-of-Phase-2 meeting with the FDA on BNC210 in PTSD — Bionomics / Neuphoria Therapeutics (IR)
  4. BNC210, an alpha7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder (ATTUNE) — NEJM Evidence 2025;4(1):EVIDoa2400380
  5. Neuphoria provides update on AFFIRM-1 Phase 3 (SAD missed); SAD discontinued, PTSD paused, strategic review — Neuphoria Therapeutics (IR)
  6. Soclenicant / BNC210 (ligand 14250) - alpha7 nicotinic ACh receptor negative allosteric modulator — IUPHAR/BPS Guide to Pharmacology