Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SP-304 · 1 trial · 1 indication
Incidences of adverse events from Baseline through the end of the Follow-up period.
| Arm | Type | Description |
|---|---|---|
| SP-304 0.3 mg | EXPERIMENTAL | SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 1.0 mg | EXPERIMENTAL | SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 3.0 mg | EXPERIMENTAL | SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days |
| SP-304 9.0 mg | EXPERIMENTAL | SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet by mouth once daily for 14 consecutive days |
| Name | Type | Description |
|---|---|---|
| SP-304 0.3 mg | DRUG | SP-304 0.3 mg |
| SP-304 1.0 mg | DRUG | SP-304 1.0 mg |
| SP-304 3.0 mg | DRUG | SP-304 3.0 mg |
| SP-304 9.0 mg | DRUG | SP-304 9.0 mg |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act \[HIP...
SP-304 is an investigational small molecule being developed for the treatment of chronic idiopathic constipation, a gastrointestinal condition characterized by persistent difficulty with bowel movements. It is currently in clinical development and has not been approved by regulatory authorities.
SP-304 is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic idiopathic constipation.
SP-304 is in Phase 2 clinical development. A Phase 2 dose-ranging study has been completed, but the drug remains investigational and has not received regulatory approval for any use.
SP-304 has one completed clinical trial, NCT01053962, a Phase 2 dose-ranging study in patients with chronic idiopathic constipation. The trial enrolled 84 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, SP-304 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial, but it has not been submitted for or granted marketing approval by the FDA or any other regulatory agency.