Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nifedipine
Nifedipine/Candesartan · 4 trials · 2 indications
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Nifedipine/Candesartan (fixed dose) | EXPERIMENTAL | - |
| Nifedipine/Candesartan (loose) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Nifedipine (Adalat, BAYA1040) | DRUG | Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID) |
| Nifedipine/Candesartan (BAY 98-7106) | DRUG | Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period) |
| Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) | DRUG | Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) . |
Inclusion Criteria: * 20 years or older * Japanese male or female * Outpatient with essential hypertension * Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study Exclusion Criteria: * Pat...
Top 9 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |
Nifedipine/Candesartan is being developed for the treatment of hypertension, including essential hypertension. It combines two blood pressure lowering agents in a single fixed-dose formulation. The program is in Phase 3 development, with completed trials conducted in Japan and Germany in adults with hypertension.
Nifedipine/Candesartan targets the calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F. The nifedipine component acts as a blocker at these L-type calcium channels, while candesartan is an angiotensin II receptor blocker. Together these mechanisms reduce blood pressure through complementary pathways.
Nifedipine/Candesartan is being developed by Bayer AG, which trades under the ticker BAYRY. The fixed-dose combination also carries the internal designation BAY 98-7106. Bayer has run the clinical program for this hypertension asset across sites in Japan and Germany.
Nifedipine/Candesartan is in Phase 3 development. It is an investigational fixed-dose combination and has not been approved. The program includes completed Phase 3 trials in hypertension as well as a Phase 1 bioequivalence study comparing the fixed-dose combination against the loose combination of its single components.
Completed studies include NCT01287260, a Phase 3 dose-comparative trial in 352 patients with hypertension in Japan; NCT01294215, a Phase 3 long-term combination study in 72 patients; NCT01355367, a Phase 3 long-term extension study in 120 patients; and NCT01350609, a Phase 1 bioequivalence study in 49 healthy male volunteers in Germany.
Yes. Nifedipine/Candesartan is also known as BAY 98-7106, its Bayer development code. The nifedipine component appears in the trial record as BAYA1040 and is also marketed as Adalat and Adalat CR. Searches for these alternative names refer to the same hypertension program.