Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XP19986 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| XP19986 CR | EXPERIMENTAL | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of XP19986 10, 20, 40 or 60 mg. |
| Placebo for XP19986 CR | PLACEBO_COMPARATOR | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of placebo. |
| Name | Type | Description |
|---|---|---|
| XP19986 CR | DRUG | - |
| Placebo for XP19986 CR | DRUG | - |
Inclusion Criteria: 1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week 2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\]) for 7 days prior to baseline (Visit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Nexium |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | PHASE2 | MHS-1031 |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
XP19986 is an investigational small molecule being studied for the treatment of gastroesophageal reflux disease (GERD). It is a controlled-release formulation of arbaclofen placarbil. The drug is in Phase 2 clinical development and is not yet approved by the FDA.
XP19986 is a prodrug of arbaclofen, which is the R-enantiomer of baclofen. It acts as a GABA-B receptor agonist. By activating GABA-B receptors, it is intended to reduce transient lower esophageal sphincter relaxations, which are a key mechanism in the development of GERD.
XP19986 is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker INDV. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with GERD.
XP19986 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not received FDA approval for any indication.
XP19986 has one completed clinical trial, identified as NCT00838396. This Phase 2 study evaluated the efficacy and safety of controlled-release arbaclofen placarbil (XP19986) in patients with GERD. The trial enrolled 58 participants in the United States and was completed.
XP19986 is the code name for arbaclofen placarbil. The drug is a controlled-release formulation of arbaclofen placarbil, which is a prodrug of arbaclofen. In clinical trials, it is referred to as XP19986 or arbaclofen placarbil.