Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aliskiren · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Aliskiren 600 mg |
| 2 | ACTIVE_COMPARATOR | Aliskiren 150 mg |
| 3 | ACTIVE_COMPARATOR | Losartan 100 mg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aliskiren | DRUG | Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period. |
| Comparator: Losartan | DRUG | Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period. |
| Comparator: Placebo to Aliskiren | DRUG | Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period. |
| Comparator: Placebo to Losartan | DRUG | Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period. |
Inclusion Criteria: * Subject is in generally good health * Subject is willing to avoid unaccustomed strenuous exercise during the study * Subject agrees to consume ONLY the study-specified diet during all domiciled periods * Subject has been a non-smoker for at least 3 months prior to study * Subj...
Top 9 of 16 competitors
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| AstraZeneca PLC | AZN | 5 | PHASE3 | Baxdrostat |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Clazakizumab |
| Alnylam Pharmaceuticals, Inc | ALNY | 2 | PHASE3 | Zilebesiran, ALN-AGT01 RVR |
| Mineralys Therapeutics, Inc. | MLYS | 1 | PHASE3 | lorundrostat |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | QCZ484, HJB647 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX340 |
Aliskiren is being studied for the treatment of hypertension, also known as high blood pressure. It is a small molecule therapeutic in the cardiovascular area. Development is at Phase 1, so it is investigational and not yet approved for prescribing. The clinical work to date has focused on hypertension in healthy male volunteers.
Aliskiren targets renin, encoded by the REN gene. It acts as an inhibitor of this enzyme. Renin is the rate-limiting step in the renin-angiotensin system, so inhibiting it is the intended mechanism for lowering blood pressure in hypertension.
Aliskiren is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for the drug in hypertension.
Aliskiren is in Phase 1 clinical development for hypertension. It is an investigational small molecule and has not completed the later-stage trials required for regulatory approval. One Phase 1 trial has been completed, and no trials are currently active.
Aliskiren has been studied in one completed Phase 1 trial, NCT00856960, titled The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127). The trial enrolled 12 healthy male volunteers aged 18 years and older, was randomized, double-blind, and placebo-controlled, and examined hypertension.