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Schizophrenia

CNS 1 original drugs
1
Novel Drugs
31
Reformulations
114
Active Trials
22
Drug Targets

CNS indication. Schizophrenia has 1 FDA-approved novel treatment, led by ALKERMES INC, with 114 active industry clinical trials across 22 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Schizophrenia Market Leaders

Companies with the most FDA-approved novel Schizophrenia drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

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Q3 2026
3-6mg QLM1016
Qilu Pharmaceutical Co., Ltd.
Estimated · stale NCT06799559
Q3 2026
Evenamide 15 mg bid
Newron Pharmaceuticals SPA
Estimated · fresh NCT07184619
Q3 2026
OLZ/SAM
Alkermes, Inc.
Estimated · fresh NCT05303064
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Schizophrenia Treatments by Mechanism

Top 7 mechanisms across 67 industry trials with a known mechanism of action.

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Atypical Antipsychotic
46 trials 2 active 17 sponsors
5HT2A/D2
14 trials 9 sponsors
5-HT1A receptor/5-HT2A receptor/D2 receptor
3 trials 1 sponsor
Dopamine-2 Receptor Antagonist
1 trials 1 sponsor
DAT
1 trials 1 sponsor
Phosphodiesterase 4 Inhibitor
1 trials 1 sponsor
5-HT2A receptor/D2 receptor
1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Schizophrenia Clinical Pipeline by Phase

568 industry-sponsored trials across 129 sponsors

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Novel Schizophrenia Drugs by Company (New molecular entities)

1 company has an FDA-approved novel drug for Schizophrenia.

Reformulations (31 drugs) Click to expand
Generic Drugs (12 ANDA approved) Click to expand

Related Indications

Other CNS indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology