Alkermes
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
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
NCT07540897
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
NCT07502443
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
NCT07455383
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
NCT06843590
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
NCT06767683
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
NCT05303064
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
NCT06555783
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
NCT06358950
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
NCT05547100
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
NCT04987658
Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
NCT03919994
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
NCT03610048
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
NCT03345979
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
NCT03201757
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
NCT03188185
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
An Insulin Sensitivity Study in Healthy Subjects
NCT02922426
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
NCT02873208
A Phase 1 Safety Study in Adults With Schizophrenia
NCT02804568
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
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
NCT02694328
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
NCT02669758
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
NCT02636842
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
NCT02634320
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
NCT02634346
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
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
NCT02508506
A Water Consumption Study of ALKS 5461 in Healthy Volunteers
NCT02521857
A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
NCT02545439
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
NCT02479308
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
NCT02504463
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
NCT02452801
A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
NCT02413281
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
NCT02320032
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
NCT02272764
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
NCT02218021
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
NCT02218008
A Long-Term Safety Study of ALKS 5461
NCT02141399
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
NCT02158546
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
NCT02158533
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
NCT02161718
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
NCT02085135
A Study of ALKS 5461 in Healthy Volunteers
NCT02068105
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT01895452
A Study of ALKS 3831 in Adults With Schizophrenia
NCT01903837
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT01626456
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
NCT01493726
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
NCT01500200
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
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
NCT01436032
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 22 |
| Phase 2 | 14 |
| Phase 3 | 25 |
| Phase 4 | 3 |
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.
Read our methodology - how this data is sourced, computed, and verified.
Related
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.