ALKS 37

PreclinicalSmall molecule

AAlkermes, Inc.

ALKS 37 is one of 2 small molecule programs targeting Narcolepsy Type 1. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Narcolepsy Type 1Recruiting

Narcolepsy Type 1Preclinical

Recruiting

Competition

Competitive Landscape

2 competitors in Narcolepsy Type 1

#DrugCompanyPhaseTrials

TAK-360

Takeda

Phase 2

1 2

ALKS 37

AAlkermes, Inc.

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Narcolepsy Type 1

NCT07455383

Q2 2030

PreclinicalRecruiting

Narcolepsy Type 1

NCT06767683

Clinical

Trials by Indication[1]

Major Depressive Disorder6 trials

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

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

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

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

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 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

Show 3 more trials

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

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

A Phase 1 Safety Study in Adults With Schizophrenia

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

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

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

ALK3 trials

A Study of ALKS 5461 in Healthy Volunteers

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

A Long-Term Safety Study of ALKS 5461

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

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

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

Constipation2 trials

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

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

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

13 more indications

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

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

Narcolepsy Type 12 trials

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Recruiting·AAlkermes, Inc.·Preclinical·NCT06767683·786 enrolled

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

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

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

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

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

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

Idiopathic Hypersomnia1 trial

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)

Active, not recruiting·AAlkermes, Inc.·Phase 2·NCT06843590·126 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: Preclinical[1]
Company: AAlkermes, Inc.

ALKS 37

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q2 2030

Trials by Indication[1]

Major Depressive Disorder6 trials

Schizophrenia6 trials

ALS3 trials

ALK3 trials

Constipation2 trials

Narcolepsy2 trials

Interaction2 trials

Narcolepsy Type 12 trials

Insulin Sensitivity1 trial

Bipolar I Disorder1 trial

MDD1 trial

Opioid Use1 trial

Hepatic Impairment1 trial

Renal Impairment1 trial

Phase 11 trial

AIN1 trial

Treatment1 trial

Idiopathic Hypersomnia1 trial

References

Drug Info

Quick Facts

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