Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as XP19986 CR
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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Phathom Pharmaceuticals, Inc. | PHAT | 2 | PHASE3 | Vonoprazan |
XP19986 was studied as a treatment for gastroesophageal reflux disease (GERD). It is a small molecule developed by Supernus Pharmaceuticals and was evaluated in a Phase 2 clinical trial in adults with GERD in the United States. It is an investigational agent rather than an approved GERD therapy.
XP19986 is developed by Supernus Pharmaceuticals, Inc., which trades under the ticker SUPN. The company sponsored the Phase 2 study of the drug in gastroesophageal reflux disease. XP19986 is also referred to as XP19986 CR, reflecting its controlled release formulation.
XP19986 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The program is investigational and has not been described as FDA approved for GERD or any other indication.
XP19986 was evaluated in the completed Phase 2 trial NCT00838396, titled a study to evaluate the efficacy and safety of controlled release arbaclofen placarbil (XP19986) in patients with gastroesophageal reflux disease. The trial enrolled 58 patients in the United States, was randomized, double blind, and placebo controlled, and included adults 18 years and older.
Yes, XP19986 CR is another name for XP19986. The CR designation refers to the controlled release formulation of arbaclofen placarbil, which is how the drug appears in its Phase 2 GERD trial. Searches for either name refer to the same Supernus Pharmaceuticals compound.