Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RDC-1036 · 1 trial · 1 indication
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
| Arm | Type | Description |
|---|---|---|
| RDC-1036 (ALKS 37) | EXPERIMENTAL | Capsules for oral administration |
| Placebo | PLACEBO_COMPARATOR | Capsules for oral administration |
| Name | Type | Description |
|---|---|---|
| RDC-1036 (ALKS 37) | DRUG | Capsules for oral administration |
| Placebo | DRUG | Capsules for oral administration |
Inclusion Criteria: * 18 to 70 years of age * Body mass index (BMI) of 19 to 35 kg/m2 at screening * Receiving prescribed opioid medication for the management of chronic, non-cancer, pain * Diagnosis of opioid-induced constipation (OIC) * Willingness to stop all laxatives and other bowel regimens f...
RDC-1036 is an investigational small molecule being developed for opioid-induced constipation (OIC), a gastrointestinal condition. It is intended for adults with OIC, as studied in a clinical trial. The drug is not approved and remains in clinical development.
RDC-1036 is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker ALKS. The company conducted a Phase 2 clinical trial of the drug in the United States.
RDC-1036 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not FDA approved. The drug remains investigational, with no active trials currently listed.
RDC-1036 has one completed clinical trial, NCT01100151, titled 'ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC).' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 60 participants in the United States.
Yes, RDC-1036 is also known as ALKS 37. The clinical trial NCT01100151 refers to the drug as both RDC-1036 and ALKS 37, indicating these names are used interchangeably for the same investigational compound.