Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Beraprost sodium modified release
Beraprost modified release · 4 trials · 1 indication
The change in Pulmonary Vascular Resistance (PVR) was evaluated from Baseline to Week 12. PVR is expressed in Wood Units or millimeters of Mercury per Liter per minute (mmHG/L/min)
The change in Cardiac Output was evaluated from Baseline to Week 12.
The change in mean Pulmonary Arterial Pressure (mPAP) was evaluated from Baseline to Week 12.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted.
A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | EXPERIMENTAL | Patients in the MTD treatment group will dose escalate weekly by 60µg b.i.d. until they reach the maximum dose of 600µg b.i.d. or they reach an intolerable dose which requires them to down-titrate by 60µg b.i.d. In these instances and at the Investigator's discretion, further attempts at dose escalation may be made. |
| Low Fixed Dose | EXPERIMENTAL | The low dose group will receive 60µg twice a day(b.i.d.) |
| High Fixed Dose | EXPERIMENTAL | Patients in the high dose group will dose escalate weekly by 60µg twice a day (b.i.d.) until they reach the fixed dose of 240µg b.i.d. Once patients in these treatment groups have reached their assigned maximum dose of active drug, |
| B.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing) |
| Q.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, q.i.d (four times a day dosing) |
| Name | Type | Description |
|---|---|---|
| Beraprost Sodium Modified Release | DRUG | 60µg Tablets, twice a day for 12 weeks |
Inclusion Criteria: 1. IRB approved written informed consent has been obtained. 2. Male or female, age 18 to 75 years (inclusive). 3. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH induced by anorexig...
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 modified release is being studied for the treatment of pulmonary arterial hypertension (PAH), a cardiovascular condition. It is an investigational small molecule developed by United Therapeutics Corporation. The clinical program has focused on PAH patients aged 18 years and older.
Beraprost modified release is being developed by United Therapeutics Corporation, which trades on the Nasdaq under the ticker UTHR. The company has sponsored the clinical trial program for this investigational therapy in pulmonary arterial hypertension.
Beraprost modified release is in Phase 2 clinical development. Four Phase 2 trials have been completed, with no active trials currently listed. The studies enrolled a total of 104 patients with pulmonary arterial hypertension.
Beraprost modified release has been evaluated in four completed Phase 2 trials: NCT00990314, NCT00989963, NCT00792571, and NCT00781885. These studies took place in the United States, Belgium, Czechia, Germany, Ireland, and Romania, and enrolled adults with pulmonary arterial hypertension.
Yes, beraprost modified release is also known as beraprost sodium modified release. Both names refer to the same investigational small molecule developed by United Therapeutics Corporation for pulmonary arterial hypertension.