Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies (14.2) ]. FDA label
Also known as Letairis, Volibris, Letairis(TM), BSF 208075
Ambrisentan · 11 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 |
| BSF 208075 | DRUG | - |
| 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...
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 |
Ambrisentan is used to treat pulmonary arterial hypertension and pulmonary hypertension, and it has also been studied in sarcoidosis-associated pulmonary hypertension and sickle cell anemia. It is a small molecule developed by Gilead Sciences, Inc. (ticker GILD) and is given to adults in the studied trials.
Ambrisentan targets the endothelin receptors EDNRA and EDNRB, acting as an antagonist. By blocking these receptors, it interferes with endothelin-1 signaling, which is involved in the narrowing of pulmonary blood vessels. This receptor blockade underlies its use in pulmonary hypertension and related conditions.
Ambrisentan is developed by Gilead Sciences, Inc., which trades under the ticker GILD. The company is the sponsor associated with the clinical development program for the drug across pulmonary hypertension and related indications.
Ambrisentan is in Phase 3 development. The program includes completed Phase 3 trials in pulmonary hypertension and pulmonary arterial hypertension, along with earlier-phase studies in sarcoidosis-associated pulmonary hypertension and sickle cell anemia. No active trials are currently listed for the drug.
Ambrisentan has been studied in five completed trials, including NCT00777920, a Phase 3 study in pulmonary hypertension with 140 participants, and NCT00578786, a long-term Phase 3 study in pulmonary arterial hypertension with 383 participants. Earlier studies include NCT00851929 in sarcoidosis-associated pulmonary hypertension and NCT02712346 in sickle cell disease.
Yes, Ambrisentan is also known by the brand name Letairis. The Phase 2 trial NCT00851929 is titled "Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension," confirming that Letairis is an alternative name for the same drug.