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PN-943 · 1 trial · 2 indications
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
| Arm | Type | Description |
|---|---|---|
| PN-943 450 mg BID | EXPERIMENTAL | Oral administration of PN-943 450 mg BID |
| PN-943 150 mg BID | EXPERIMENTAL | Oral administration of PN-943 150 mg BID |
| Placebo BID | PLACEBO_COMPARATOR | Oral administration of matching placebo |
| Name | Type | Description |
|---|---|---|
| PN-943 | DRUG | Administered by the oral route BID for the duration of the study. |
| Placebo | DRUG | Administered by the oral route BID for 12 weeks. |
Key Inclusion Criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. Diagnosis of UC supported by appropriate documen...
PN-943 is an investigational oral small molecule being developed for the treatment of moderate to severe active ulcerative colitis, a chronic inflammatory bowel disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
PN-943 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PTGX. The company is conducting clinical trials to evaluate the safety and efficacy of PN-943 in patients with ulcerative colitis.
PN-943 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved for commercial use. Further studies may be needed to establish its safety and efficacy profile.
PN-943 has been studied in a Phase 2 clinical trial identified as NCT04504383, titled 'PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)'. This randomized, double-blind, placebo-controlled trial enrolled 169 participants across multiple countries, including the United States, Canada, and several European nations.
PN-943 is a distinct investigational compound developed by Protagonist Therapeutics. No alternative names for PN-943 have been disclosed in public clinical trial registries. It is being evaluated specifically for its potential role in treating ulcerative colitis.
The Phase 2 trial of PN-943 was a randomized, double-blind, placebo-controlled study. It enrolled 169 adults with moderate to severe active ulcerative colitis. The trial was completed and did not require biomarker-based patient selection. Participants were at least 18 years old, and the study was conducted internationally.