Social anxiety disorder drug pipeline
- ICD-11 6B04
- MeSH D000072861
5 compounds from 5 companies are in active clinical development for social anxiety disorder, including 2 at Phase 3 or beyond.
Mechanisms: Small molecule (4) · Psychedelic (1)
Pipeline data compiled September 2026 · every fact sourced.
Upcoming readouts & recent results
FDA meeting on potential future Phase 3 registrational pathway for fasedienol in social anxiety disorder expected during Q3 2026 ↗
Phase 3 VQW-765 social anxiety disorder topline results expected by end of 2026 ↗
ClinicalTrials.gov estimated primary completion of the SOAR Phase 2 study (NCT07323784): January 2027 (estimated study completion also January 2027). ↗
Topline data from the Phase 2 SOAR proof-of-concept study of NTX-1472 210 mg once daily versus placebo in generalized social anxiety disorder — safety/tolerability primary, LSAS the key efficacy secondary — expected 1H 2027. ↗
Phase 2 repeat-dose study topline: safety objective met for two-dose regimen; efficacy numerically separated from placebo but not statistically significant (exploratory) ↗
PALISADE-4 Phase 3 topline: fasedienol missed primary and secondary endpoints in social anxiety disorder public speaking challenge ↗
PALISADE-3 open-label extension preliminary data: fasedienol well-tolerated over up to 12 months of as-needed use; clinically relevant improvement on LSAS and SPIN over four months ↗
PALISADE-3 missed its primary SUDS endpoint (large placebo response); no secondary difference. ↗
Compounds in development (5)
| Compound | Company | Phase | Status | Mechanism |
|---|---|---|---|---|
| Fasedienol (PH94B)Fast Track | Vistagen Therapeutics, Inc. | Phase 3 | Active | Nasal chemosensory receptor neurons Agonist |
| VQW-765 | Vanda Pharmaceuticals Inc. | Phase 3 | Recruiting | alpha7 nAChR Partial agonist |
| EMP-01 (oral R-MDMA) | EmpathBio, Inc. | Phase 2 | Completed | SERT Releaser |
| NTX-1472 | Newleos Therapeutics, Inc. | Phase 2 | Recruiting | V1a receptor Antagonist |
| BNC210 (soclenicant) | Neuphoria Therapeutics, Inc. | Discontinued | Discontinued | alpha7 nAChR NAM |
Trials recruiting now (6)
6 drug-interventional social anxiety disorder trials recruiting now, of 96 registered interventional trials. Browse all on ClinicalTrials.gov →
Cannabidiol, Placebo
Sertraline (Oral Antidepressant)
VQW-765, Placebo
NTX-1472, Placebo
Fasedienol Nasal Spray - Placebo Nasal Spray, Fasedienol Nasal Spray - Fasedienol Nasal Spray, Placebo Nasal Spray - Placebo Nasal Spray
- UnknownNeural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Sertraline
Frequently asked
- How many drugs are in development for social anxiety disorder?
- 5 compounds from 5 companies are in active clinical development for social anxiety disorder, including 2 at Phase 3 or beyond.
- Which social anxiety disorder drugs are in Phase 3?
- Phase 3 (or later) programs for social anxiety disorder include Fasedienol (PH94B) and VQW-765.
- What are the next social anxiety disorder trial readouts?
- Upcoming catalysts include Fasedienol (PH94B) (Q3 2026), VQW-765 (End of 2026), NTX-1472 (January 2027) and NTX-1472 (1H 2027).
- How many clinical trials are recruiting for social anxiety disorder?
- 6 drug-interventional social anxiety disorder trials are currently recruiting participants, out of 96 registered interventional trials.