Alkermes

66 total trials 6 currently recruiting 58 completed

Alkermes sponsors 66 registered US clinical trials on ClinicalTrials.gov, 6 of them currently recruiting, and 58 completed. 28 of these trials are in Phase 3-4 (later-stage) and 36 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Schizophrenia, with 7 trials.

Trial Pipeline

66 total, page 1 of 2

RECRUITING Phase 3

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

NCT07540897

RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

NCT07502443

RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

NCT07455383

RECRUITING Phase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

NCT06843590

RECRUITING Phase 2

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

NCT06767683

RECRUITING Phase 3

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

COMPLETED Phase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783

COMPLETED Phase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

NCT06358950

COMPLETED Phase 1

Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100

COMPLETED Phase 1

Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

NCT04987658

COMPLETED

Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)

NCT03919994

TERMINATED Phase 3

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

NCT03610048

COMPLETED Phase 3

A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

NCT03345979

COMPLETED Phase 3

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

NCT03201757

COMPLETED Phase 3

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

NCT03188185

COMPLETED Phase 3

Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

NCT03187769

COMPLETED Phase 1

An Insulin Sensitivity Study in Healthy Subjects

NCT02922426

COMPLETED Phase 3

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02873208

COMPLETED Phase 1

A Phase 1 Safety Study in Adults With Schizophrenia

NCT02804568

COMPLETED Phase 3

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

NCT02696434

COMPLETED Phase 3

A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

NCT02694328

COMPLETED Phase 3

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02669758

COMPLETED Phase 1

A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

NCT02636842

COMPLETED Phase 4

A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

NCT02634320

COMPLETED Phase 3

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

NCT02634346

COMPLETED Phase 3

Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

NCT02537574

COMPLETED Phase 1

Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

NCT02508506

COMPLETED Phase 1

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

NCT02521857

COMPLETED Phase 1

A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

NCT02545439

COMPLETED Phase 1

A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

NCT02479308

COMPLETED Phase 1

A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

NCT02504463

COMPLETED Phase 1

Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function

NCT02452801

COMPLETED Phase 1

A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

NCT02413281

COMPLETED Phase 1

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

NCT02320032

COMPLETED Phase 1

A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

NCT02272764

COMPLETED Phase 1

A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

NCT02218021

COMPLETED Phase 3

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

NCT02218008

COMPLETED Phase 3

A Long-Term Safety Study of ALKS 5461

NCT02141399

COMPLETED Phase 3

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

NCT02158546

COMPLETED Phase 3

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533

COMPLETED Phase 2

A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

NCT02161718

COMPLETED Phase 3

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

NCT02085135

COMPLETED Phase 1

A Study of ALKS 5461 in Healthy Volunteers

NCT02068105

COMPLETED Phase 3

An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT01895452

COMPLETED Phase 2

A Study of ALKS 3831 in Adults With Schizophrenia

NCT01903837

COMPLETED Phase 3

A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT01626456

COMPLETED Phase 1

A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

NCT01493726

COMPLETED Phase 2

A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

NCT01500200

COMPLETED Phase 3

A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

NCT01469039

TERMINATED Phase 3

Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

NCT01436032

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What the Pipeline for Alkermes Shows

According to the ClinicalTrials.gov registry, Alkermes is linked to 66 US clinical trials across every stage of research activity. Of those, 6 studies are currently recruiting, about 9% of the sponsor's indexed portfolio, and 58 are already marked complete, representing roughly 88% of the total.

The phase mix for Alkermes reports 28 late-stage studies (Phase 3 and Phase 4 combined) and 36 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Alkermes is Schizophrenia with 7 linked trials, and 9 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.