Anxiety & Trauma Disorders

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.

5Compounds
5Companies
2Phase 3+
4Upcoming readouts
6Trials recruiting

Mechanisms: Small molecule (4) · Psychedelic (1)

Pipeline data compiled September 2026 · every fact sourced.

Upcoming readouts & recent results

  • Q3 2026AnticipatedFasedienol (PH94B)Regulatory

    FDA meeting on potential future Phase 3 registrational pathway for fasedienol in social anxiety disorder expected during Q3 2026

  • End of 2026AnticipatedVQW-765Topline dataNCT07221578

    Phase 3 VQW-765 social anxiety disorder topline results expected by end of 2026

  • January 2027AnticipatedNTX-1472Registry resultsNCT07323784

    ClinicalTrials.gov estimated primary completion of the SOAR Phase 2 study (NCT07323784): January 2027 (estimated study completion also January 2027).

  • 1H 2027AnticipatedNTX-1472Topline dataNCT07323784

    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.

  • 2026-08-06ReportedFasedienol (PH94B)Topline datamixed

    Phase 2 repeat-dose study topline: safety objective met for two-dose regimen; efficacy numerically separated from placebo but not statistically significant (exploratory)

  • 2026-06-30ReportedFasedienol (PH94B)Topline datamissedNCT06615557

    PALISADE-4 Phase 3 topline: fasedienol missed primary and secondary endpoints in social anxiety disorder public speaking challenge

  • 2026-05-12ReportedFasedienol (PH94B)Interim analysismet

    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

  • 2025-12-17ReportedFasedienol (PH94B)Topline datamissedNCT06358651

    PALISADE-3 missed its primary SUDS endpoint (large placebo response); no secondary difference.

See the full catalyst calendar →

Compounds in development (5)

CompoundCompanyPhaseStatusMechanism
Fasedienol (PH94B)Fast TrackVistagen Therapeutics, Inc.Phase 3ActiveNasal chemosensory receptor neurons Agonist
VQW-765Vanda Pharmaceuticals Inc.Phase 3Recruitingalpha7 nAChR Partial agonist
EMP-01 (oral R-MDMA)EmpathBio, Inc.Phase 2CompletedSERT Releaser
NTX-1472Newleos Therapeutics, Inc.Phase 2RecruitingV1a receptor Antagonist
BNC210 (soclenicant)Neuphoria Therapeutics, Inc.DiscontinuedDiscontinuedalpha7 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 →

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.