Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
Beraprost 314d Modified Release is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH). It is a prostacyclin analogue that is being studied as an add-on therapy to Tyvaso (treprostinil) in patients with PAH. The drug is currently in Phase 3 clinical development.
Beraprost 314d Modified Release is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Pulmonary Arterial Hypertension.
Beraprost 314d Modified Release is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, known as BEAT, has been completed, and the drug remains under investigation for the treatment of Pulmonary Arterial Hypertension.
Beraprost 314d Modified Release has been studied in one completed Phase 3 clinical trial with the identifier NCT01908699. This trial, titled 'Beraprost-314d Added-on to Tyvaso® (BEAT)', enrolled 273 participants with Pulmonary Arterial Hypertension. The study was randomized, double-blind, and controlled, and took place in the United States and Israel.
No, Beraprost 314d Modified Release is not the same as Tyvaso. Tyvaso (treprostinil) is a separate medication also developed by United Therapeutics. In the BEAT clinical trial (NCT01908699), Beraprost 314d Modified Release was studied as an add-on therapy to Tyvaso in patients with Pulmonary Arterial Hypertension.