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Schizophrenia

CNS 1 original drugs
1
Novel Drugs
30
Reformulations
124
Active Trials
22
Drug Targets

CNS indication. Schizophrenia has 1 FDA-approved novel treatment, led by ALKERMES, with 124 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
NaBen®
SyneuRx International (Taiwan) Corp
Estimated · stale NCT03094429
Q3 2026
OLZ/SAM
Alkermes, Inc.
Estimated · aging NCT05303064
Q4 2026
SEP-363856
Otsuka Pharmaceutical Development & Commercialization, Inc.
Estimated · fresh NCT06894212
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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 18 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

577 industry-sponsored trials across 133 sponsors

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Novel Schizophrenia Drugs by Company (New molecular entities)

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

Reformulations (30 drugs) Click to expand
Generic Drugs (11 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