Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSP-002358 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI) | ACTIVE_COMPARATOR | - |
| SSP-002358 (0.5 mg) + PPI | ACTIVE_COMPARATOR | - |
| SSP-002358 (2.0 mg) + PPI | ACTIVE_COMPARATOR | - |
| Placebo + PPI | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SSP-002358 (0.1 mg) + PPI | DRUG | 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI |
| SSP-002358 (0.5 mg) + PPI | DRUG | 0.5 mg tablet t.i.d. taken in addition to a PPI |
| SSP-002358 (2.0 mg) + PPI | DRUG | 2.0 mg tablet t.i.d. taken in addition to a PPI |
| Placebo + PPI | DRUG | Placebo t.i.d. taken in addition to a PPI |
Inclusion Criteria: 1. Written Informed Consent Form signed voluntarily before the first study-related activity. 2. Aged between 18 and 70 years, inclusive. 3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy. 4. Subjects with symptoms...
SSP-002358 is being developed for the treatment of gastroesophageal reflux disease, or GERD. It is a small molecule therapeutic candidate studied in combination with a proton pump inhibitor. Takeda Pharmaceutical Company Limited is developing the asset, which has completed a Phase 2 clinical trial in adults with GERD.
SSP-002358 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the drug candidate in gastroesophageal reflux disease, including the completed Phase 2 trial NCT01472939.
SSP-002358 has completed a Phase 2 clinical trial and is an investigational drug candidate, not an approved therapy. The Phase 2 study, NCT01472939, evaluated the selective 5-HT4 receptor agonist together with a proton pump inhibitor in subjects with gastroesophageal reflux disease.
SSP-002358 has been studied in one Phase 2 clinical trial, NCT01472939, titled Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD). The trial was completed and enrolled 480 participants across the United States, Czechia, Germany, Latvia, Poland, and Romania.