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Data updated: Sep 20, 2026

ALKERMES

Specialty
RespiratoryGastroenterology Execution: Good

ALKERMES is a specialty pharmaceutical company focused on Respiratory, Gastroenterology. Key products include LYBALVI.

2006
Since
5
Drugs
-
Trials
0
New Drugs (2yr)
Modality:
5 Small Molecules

FDA Novel Drug Designations

(2021)
1 Novel
See 1 novel approval →
2021 LYBALVI (OLANZAPINE)

ALKERMES at a Glance

  • Fast trial execution (13 months median completion)

ALKERMES's Key Drugs

ALKERMES's core commercial portfolio centers on LYBALVI, LUMRYZ, ARISTADA, spanning Respiratory and Gastroenterology — its most strategically important drugs approved in the last 15 years.

ALKERMES's Recent FDA Approvals

New NDA/BLA approvals for ALKERMES over the last two years — novel drugs only, excluding generics and label supplements.

No recent approvals

ALKERMES's Therapeutic Areas

ALKERMES's approved drugs and pipeline span 2 therapeutic areas, led by Respiratory and Gastroenterology, across 0 biologic and 5 small-molecule drugs. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Respiratory 67%
0 drugs Phase 2: 1
Gastroenterology 33%
0 drugs Phase 1: 1

ALKERMES's Top Competitors

ALKERMES's closest competitors by therapeutic-area and drug-target overlap include MALLINCKRODT, LEGACY, and COREPHARMA. Ranked by overlap in therapeutic areas and drug targets across approved drugs and pipeline.

ALKERMES Pipeline Snapshot

ALKERMES has 2 active clinical programs from ClinicalTrials.gov — 0 Phase 3, 1 Phase 2 and 1 Phase 1.

0
Phase 3
1
Phase 2
1
Phase 1

Phase 3 Readout Calendar Pro

6 Phase 3 trials with confidence-graded primary completion dates.

Full calendar →
Q3 2026
OLZ/SAM
Schizophrenia
Estimated · aging NCT05303064
Q2 2027
ALKS 2680 Dose 1
Narcolepsy Type 1
Estimated · fresh NCT07455383
Q2 2027
ALKS 2680 Dose 1
Narcolepsy Type 2
Estimated · fresh NCT07502443
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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.

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • LYBALVI leads revenue
  • 4 key drugs tracked

Trial Catalysts

  • Respiratory pipeline focus
  • 6 Phase 3 readouts tracked
View readout calendar →

Patent Risk

  • Patent expiration timeline
  • Revenue at risk analysis

Compare Companies

  • Side-by-side pipeline analysis
  • Revenue & market share comparison

Execution Intelligence

  • Phase 3: 20/27 completed
  • Speed: 13 months avg
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Revenue forecasts • Trial milestones • Patent risk modeling

How We Calculate These Metrics

Execution Quality Score

Measures trial completion rates weighted by phase importance. Phase 3 trials count 4x more than Phase 1 because late-stage completion is harder and more valuable.

What counts as "completed": A trial that reached its planned endpoint and reported results. Trials that were terminated early, withdrawn, or suspended are not counted as completed—these often indicate safety issues, lack of efficacy, or strategic pivots.

  • Excellent (80%+): Top-tier execution, most trials reach planned endpoints
  • Good (60-79%): Strong execution with occasional early terminations
  • Fair (40-59%): Average execution, notable rate of terminated/withdrawn trials
  • Needs Improvement (under 40%): High termination rates, execution challenges