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ALKS 33

Phase 2

Alcohol Dependence | Small molecule | Psychiatry |Alkermes plc|Last Updated: Aug 7, 2012

Target and mechanism

ModalitySmall molecule

Also known as ALKS33, ALKS 37

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment406

FDA Designations

No designations recorded

Clinical trial landscape

ALKS 33 · 3 trials · 3 indications

Phase 2 3
NCT01418092ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)OIC
COMPLETED91 Analytics
NCT01382797ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)Opioid-induced Constipation
COMPLETED157 Analytics
NCT00981617ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol DependenceAlcohol Dependence
COMPLETED406 Analytics
PHASE2COMPLETED
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
OIC
NCT0141809291
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PHASE2COMPLETED
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
Opioid-induced Constipation
NCT01382797157
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PHASE2COMPLETED
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
Alcohol Dependence
NCT00981617406
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Study Endpoints

Primary Endpoints

Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
Weeks 1 through 4 of treatment
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
4 weeks

Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.

Percent of subjects abstinent from heavy drinking
12 Weeks

Secondary Endpoints

Percent of subjects abstinent from any drinking
12 Weeks
Percent of days abstinent from heavy drinking
12 Weeks
Percent of days abstinent from any alcohol
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORCapsules for oral administration
ALKS 37EXPERIMENTALCapsules for oral administration
ALKS33 (RDC-0313) (1 mg)EXPERIMENTAL1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
ALKS33 (RDC-0313) (2.5 mg)EXPERIMENTAL2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
ALKS33 (RDC-0313) (10 mg)EXPERIMENTAL10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration

Interventions

NameTypeDescription
ALKS 37DRUGCapsules for oral administration
PlaceboDRUGCapsules for oral administration
ALKS33 (RDC-0313) (1 mg)DRUG1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
ALKS33 (RDC-0313) (2.5 mg)DRUG2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
ALKS33 (RDC-0313) (10 mg)DRUG10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Are at least 18 years of age at time of consent * Have a body mass index (BMI)of 19 to 35 kg/m2 at screening * Are receiving prescribed opioid medication for the management of chronic, non-cancer pain * Meet the criteria of OIC * Agree to use an acceptable method of contracept...

Countries:United States
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Frequently asked questions about ALKS 33

What is ALKS 2680 used for?

ALKS 2680 is an investigational small molecule being developed for narcolepsy type 1, narcolepsy type 2, opioid-induced constipation, and alcohol dependence. It is currently in Phase 3 clinical trials for narcolepsy type 1. The drug is not approved and remains in clinical development.

What does ALKS 2680 target?

ALKS 2680 targets the orexin 2 receptor, a receptor involved in regulating wakefulness and sleep. By acting on this receptor, the drug is being studied for its potential effects in neurological conditions. This mechanism is relevant to its development for narcolepsy type 1 and type 2.

Who makes ALKS 2680?

ALKS 2680 is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker ALKS. The company is conducting Phase 3 clinical trials for the drug in narcolepsy type 1 and has completed earlier studies in other indications.

What phase is ALKS 2680 in?

ALKS 2680 is in Phase 3 clinical development for narcolepsy type 1. Two Phase 3 trials are currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities. Earlier Phase 2 studies were completed for alcohol dependence and opioid-induced constipation.

What clinical trials is ALKS 2680 in?

ALKS 2680 is being evaluated in two Phase 3 trials for narcolepsy type 1: NCT07455383 and NCT07540897, both recruiting 150 adults. Completed Phase 2 trials include NCT00981617 for alcohol dependence and NCT01382797 for opioid-induced constipation. All trials are randomized, double-blind, and placebo-controlled.

Is ALKS 2680 the same as ALKS33 or ALKS 37?

ALKS 2680 is a distinct drug from ALKS33 and ALKS 37. The completed trials for alcohol dependence and opioid-induced constipation tested ALKS33 and ALKS 37, respectively, which are separate compounds. ALKS 2680 is being studied specifically in narcolepsy type 1 trials.