Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Beraprost Sodium 314d Modified Release Tablets
Beraprost 314d Modified Release · 1 trial · 1 indication
The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response. The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint.
| Arm | Type | Description |
|---|---|---|
| Beraprost Sodium 314d Modified Release Tablets | EXPERIMENTAL | Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration. |
| Placebo | EXPERIMENTAL | Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR. |
| Name | Type | Description |
|---|---|---|
| Beraprost Sodium 314d Modified Release Tablets | DRUG | Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration |
| Placebo | DRUG | Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR |
Inclusion Criteria The following are inclusion criteria to be enrolled in this study: 1. Male or female, age 18 to 80 years (inclusive). 2. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH associated w...
Top 13 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 8 | PHASE3 | Sotatercept, Riociguat, Frespaciguat |
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | selexipag, Macitentan |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606, LIQ861 Treprostinil, LIQ861 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | Levosimendan (TNX-103) |
| Inhibikase Therapeutics, Inc. | IKT | 2 | PHASE3 | IKT-001 |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Tectonic Therapeutic Inc | TECX | 2 | PHASE2 | TX45 |
| Gossamer Bio, Inc. | GOSS | 1 | PHASE3 | Seralutinib |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Beraprost 314d Modified Release is an investigational oral small molecule therapy being developed by United Therapeutics Corporation for pulmonary arterial hypertension. It is a modified-release tablet formulation of beraprost sodium designed for once-daily dosing. It has completed a Phase 3 clinical trial and is not approved for commercial use.
Beraprost 314d Modified Release is being developed for the treatment of pulmonary arterial hypertension, a progressive cardiovascular condition characterized by high blood pressure in the arteries of the lungs. The drug is intended for adults 18 years and older. It remains investigational and has not been approved for any indication.
Beraprost 314d Modified Release is developed by United Therapeutics Corporation, a biotechnology company traded on the Nasdaq under the ticker symbol UTHR. United Therapeutics focuses on therapies for pulmonary hypertension and organ manufacturing. The company sponsored the Phase 3 BEAT trial evaluating this drug candidate.
Beraprost 314d Modified Release has completed a Phase 3 clinical trial and is in late-stage clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. No active trials are currently listed for this drug candidate.
Beraprost 314d Modified Release was evaluated in the Phase 3 BEAT trial, registered as NCT01908699, titled Beraprost-314d Added-on to Tyvaso. The trial enrolled 273 adults with pulmonary arterial hypertension across the United States and Israel. It was randomized, double-blind, controlled, and has been completed.
Yes, Beraprost 314d Modified Release is also known as Beraprost Sodium 314d Modified Release Tablets. Both names refer to the same investigational oral formulation developed by United Therapeutics for pulmonary arterial hypertension. The modified-release design distinguishes it from immediate-release beraprost formulations.