ALKS 37

Phase 3Small molecule

AAlkermes, Inc.

ALKS 37 is one of 159 small molecule programs targeting Constipation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

158

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bipolar I DisorderActive, not recruiting

Idiopathic HypersomniaActive, not recruiting

NarcolepsyActive, not recruiting

Major Depressive DisorderActive, not recruiting

SchizophreniaActive, not recruiting

Bipolar I DisorderPhase 3

Active, not recruiting

Idiopathic HypersomniaPhase 2/Phase 3

Active, not recruiting

NarcolepsyPhase 2

Active, not recruiting

Major Depressive DisorderPhase 3

Active, not recruiting

SchizophreniaPhase 3

Active, not recruiting

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

ALKS 37

AAlkermes, Inc.

Phase 3

6 2

Celexa

AbbVie

Preclinical

4 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 6

Zocor

OOrganon and Co

Preclinical

6 7

Depakote

Ibrance

Lunesta

3 10

Inversine

TTargacept Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Idiopathic Hypersomnia

NCT06843590

Q2 2027

Phase 3Recruiting

Narcolepsy Type 1

NCT07455383

Q2 2028

Phase 2/3Recruiting

Idiopathic Hypersomnia

NCT06767683

Clinical

Trials by Indication[1]

Major Depressive Disorder6 trials

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

Completed·AAlkermes, Inc.·Phase 3·NCT03188185·278 enrolled

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

Terminated·AAlkermes, Inc.·Phase 3·NCT03610048·175 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT02218008·407 enrolled

Show 3 more trials

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

Completed·AAlkermes, Inc.·Phase 2·NCT01500200·142 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT02158546·447 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT02085135·66 enrolled

Schizophrenia6 trials

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

Completed·AAlkermes, Inc.·Phase 3·NCT02694328·561 enrolled

A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Completed·AAlkermes, Inc.·Phase 1·NCT01493726·88 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT02873208·266 enrolled

Show 3 more trials

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

Completed·AAlkermes, Inc.·Phase 3·NCT01469039·623 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT02669758·281 enrolled

A Phase 1 Safety Study in Adults With Schizophrenia

Completed·AAlkermes, Inc.·Phase 1·NCT02804568·42 enrolled

ALK3 trials

A Long-Term Safety Study of ALKS 5461

Completed·AAlkermes, Inc.·Phase 3·NCT02141399·1,485 enrolled

A Study of ALKS 5461 in Healthy Volunteers

Completed·AAlkermes, Inc.·Phase 1·NCT02068105·104 enrolled

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Completed·AAlkermes, Inc.·Phase 1·NCT02521857·30 enrolled

ALS3 trials

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

Completed·AAlkermes, Inc.·Phase 1·NCT02479308·129 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT01895452·291 enrolled

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

Completed·AAlkermes, Inc.·Phase 3·NCT01626456·478 enrolled

Constipation2 trials

ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Completed·AAlkermes, Inc.·Phase 2·NCT01382797·157 enrolled

ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Completed·AAlkermes, Inc.·Phase 2·NCT01418092·91 enrolled

13 more indications

Interaction2 trials

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

Completed·AAlkermes, Inc.·Phase 1·NCT02545439·24 enrolled

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

Completed·AAlkermes, Inc.·Phase 1·NCT02272764·24 enrolled

Narcolepsy2 trials

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

Completed·AAlkermes, Inc.·Phase 2·NCT06555783·93 enrolled

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

Completed·AAlkermes, Inc.·Phase 2·NCT06358950·92 enrolled

Idiopathic Hypersomnia2 trials

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

Recruiting·AAlkermes, Inc.·Phase 2/3·NCT06767683·256 enrolled

A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

Recruiting·AAlkermes, Inc.·Phase 2·NCT06843590·126 enrolled

Insulin Sensitivity1 trial

An Insulin Sensitivity Study in Healthy Subjects

Completed·AAlkermes, Inc.·Phase 1·NCT02922426·60 enrolled

Bipolar I Disorder1 trial

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

Completed·AAlkermes, Inc.·Phase 3·NCT03187769·426 enrolled

Hepatic Impairment1 trial

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

Completed·AAlkermes, Inc.·Phase 1·NCT02452801·40 enrolled

Renal Impairment1 trial

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

Completed·AAlkermes, Inc.·Phase 1·NCT02508506·22 enrolled

MDD1 trial

ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

Completed·AAlkermes, Inc.·Phase 1/2·NCT01381107·32 enrolled

Opioid Use1 trial

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

Completed·AAlkermes, Inc.·Phase 1·NCT02413281·56 enrolled

Treatment1 trial

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

Completed·AAlkermes, Inc.·Phase 3·NCT03201757·523 enrolled

Phase 11 trial

Phase 1 ALKS 1140 in Healthy Adults

Terminated·AAlkermes, Inc.·Phase 1·NCT05019105·20 enrolled

AIN1 trial

ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine

Completed·AAlkermes, Inc.·Phase 1·NCT01366001·33 enrolled

Narcolepsy Type 11 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)

Recruiting·AAlkermes, Inc.·Phase 3·NCT07455383·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for ALKS 37. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ALKS 37 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ALKS 37. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Alkermes, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAlkermes, Inc.

ALKS 37

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q2 2028

Trials by Indication[1]

Major Depressive Disorder6 trials

Schizophrenia6 trials

ALK3 trials

ALS3 trials

Constipation2 trials

Interaction2 trials

Narcolepsy2 trials

Idiopathic Hypersomnia2 trials

Insulin Sensitivity1 trial

Bipolar I Disorder1 trial

Hepatic Impairment1 trial

Renal Impairment1 trial

MDD1 trial

Opioid Use1 trial

Treatment1 trial

Phase 11 trial

AIN1 trial

Narcolepsy Type 11 trial

References

Drug Info

Quick Facts

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