Approval Probability
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Camicinal · 1 trial · 1 indication
The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84 |
| Camicinal 25mg | EXPERIMENTAL | Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning |
| Camicinal | DRUG | Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning |
Inclusion Criteria: * Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 \[HbA1c\] \<=11.0%) * Male or female between 18 and 80 years of age, inclusive. * Patient has gastroparesis at screening. A patient is eligible if one of the following criteria are met: Gastric half-time of emptying \>upp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |
Camicinal is an investigational small molecule being developed for gastroparesis, a condition in which the stomach empties too slowly. It is intended for patients with type 1 and type 2 diabetes who have gastroparesis. The drug is not approved and remains in clinical development.
Camicinal is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical development for gastroparesis.
Camicinal is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.
Camicinal has one completed Phase 2 clinical trial with the identifier NCT02210000. This study evaluated the effect of Camicinal on gastroparesis symptoms in 114 diabetic subjects with gastroparesis. The trial was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
Camicinal is also known by the code name GSK962040. It is a small molecule being developed by GSK plc for the treatment of gastroparesis. The drug has completed a Phase 2 clinical trial and is not currently in active development.