TheraRadar

Insomnia

Sleep 2 original drugs
2
Novel Drugs
9
Reformulations
59
Active Trials
7
Drug Targets

Phase 3 Readouts Pro

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

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Q2 2026
Tasimelteon
Vanda Pharmaceuticals
Estimated · fresh NCT04652882
Q4 2026
Ramelteon
Nanjing Chia-tai Tianqing Pharmaceutical
Estimated · stale NCT06512363
Q2 2027
Suvorexant
Merck
Estimated · fresh NCT06655883
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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.

Treatments by Mechanism

Top 5 mechanisms across 20 industry trials with a known mechanism of action.

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Melatonin Receptor Agonist
7 trials 2 active 3 sponsors
Orexin Receptor Antagonist
8 trials 1 active 2 sponsors
GABA receptor
3 trials 2 sponsors
alpha 2 -delta site
1 trials 1 sponsor
Benzodiazepine Antagonist
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.

Clinical Pipeline by Phase

124 industry-sponsored trials across 57 sponsors

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Reformulations (9 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Generic Drugs (7 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other Sleep 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