Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ambrisentan · 10 trials · 4 indications
The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).
The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: \>3.0 and \</= 5.0 x ULN, \>5.0 and \</= 8.0 x ULN, and \>8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
| Arm | Type | Description |
|---|---|---|
| Ambrisentan | EXPERIMENTAL | Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study. |
| sarcoidosis associated pulmonary hypertension | EXPERIMENTAL | sarcoidosis associated pulmonary hypertension |
| Treatment | EXPERIMENTAL | Ambrisentan 5 mg PO daily |
| Placebo | PLACEBO_COMPARATOR | One inactive pill PO daily |
| Name | Type | Description |
|---|---|---|
| Ambrisentan | DRUG | Tablet administered orally once daily |
| Placebo | DRUG | One inactive pill daily for twelve weeks |
Key Inclusion Criteria: * Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants participating i...
| 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 |
Ambrisentan is used for pulmonary hypertension, sarcoidosis, pulmonary arterial hypertension, and sickle cell anemia. It is a small molecule being developed by Gilead Sciences, Inc. (GILD). The drug is currently in Phase 2 clinical development for these indications.
Ambrisentan is an endothelin receptor antagonist, as indicated by its role in conditions like pulmonary arterial hypertension. It works by blocking the effects of endothelin-1, a peptide that causes blood vessel constriction. This mechanism is relevant to its use in pulmonary hypertension and related disorders.
Ambrisentan is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various conditions.
Ambrisentan is in Phase 2 clinical development. It has completed five clinical trials, including Phase 1, Phase 2, and Phase 3 studies, with a total enrollment of 826 participants. The drug is not yet approved and remains investigational.
Ambrisentan has been studied in several completed clinical trials, including NCT00423202 and NCT00423748 for pulmonary arterial hypertension, NCT00851929 for sarcoidosis-associated pulmonary hypertension, and NCT02712346 for sickle cell anemia. These trials have all been completed.
Yes, Ambrisentan is also known as Letairis. In clinical trials, it is referred to as Ambrisentan (Letairis), such as in the study NCT00851929 for sarcoidosis-associated pulmonary hypertension. This alternative name is used in medical and research contexts.