Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1325760A · 3 trials · 3 indications
An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.
| Arm | Type | Description |
|---|---|---|
| GSK1325760A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK1325760A | DRUG | 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW. |
Inclusion Criteria: * Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816) * Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator * Subjects who request ...
| 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 |
GSK1325760A is an investigational small molecule studied for pulmonary arterial hypertension and hypertension. It has been evaluated in healthy subjects and in patients with pulmonary arterial hypertension, including a long-term extension study. The drug is not approved and remains in clinical development.
GSK1325760A is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has sponsored clinical trials of the drug in healthy subjects and in patients with pulmonary arterial hypertension.
GSK1325760A has completed Phase 1, Phase 2, and Phase 3 clinical trials. The Phase 1 study was in healthy Japanese subjects, the Phase 2 study evaluated efficacy in pulmonary arterial hypertension, and the Phase 3 study was a long-term extension. The drug remains investigational.
GSK1325760A has been studied in three completed trials: NCT00424034, a Phase 1 study in healthy Japanese subjects; NCT00540436, a Phase 2 efficacy and safety study in pulmonary arterial hypertension; and NCT00554619, a Phase 3 long-term extension study. All trials are completed.
No alternative names for GSK1325760A have been disclosed. The drug is identified solely by its compound number GSK1325760A in clinical trial records and by the developer GSK plc.