Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RDC-1036 (ALKS 37)
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 studied for opioid-induced constipation, a gastrointestinal condition in adults taking opioid pain medications. It was evaluated in a Phase 2 clinical trial in adults with opioid-induced constipation. RDC-1036 has not been approved by the FDA and remains in clinical development.
RDC-1036 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. Alkermes sponsored the Phase 2 study of RDC-1036 in adults with opioid-induced constipation. The drug is an investigational asset in the company's gastrointestinal pipeline.
RDC-1036 is in Phase 2 development. One Phase 2 trial, ALK37-003, has been completed, and no trials are currently active. The study enrolled 60 adults with opioid-induced constipation. RDC-1036 is investigational and has not received FDA approval.
RDC-1036 has been studied in one clinical trial: NCT01100151, also called ALK37-003, a Phase 2 study of RDC-1036 (ALKS 37) in adults with opioid-induced constipation. The trial was completed, enrolled 60 participants, and was conducted in the United States.
Yes. RDC-1036 is also known as ALKS 37, and the two names refer to the same investigational compound. The Phase 2 trial in opioid-induced constipation was titled ALK37-003, reflecting the ALKS 37 designation. Alkermes plc is the developer of RDC-1036.
The Phase 2 trial of RDC-1036, NCT01100151 or ALK37-003, was a randomized, double-blind, placebo-controlled study in adults with opioid-induced constipation. It enrolled 60 participants aged 18 years and older in the United States and has been completed.