Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nifedipine OD · 1 trial · 1 indication
Changes of sitting SBP and DBP (trough values) from baseline (ie \[trough BP at the end of each period during the double-blind treatment period\] minus \[trough BP at the end of the baseline treatment period\])
| Arm | Type | Description |
|---|---|---|
| Nifedipine (Adalat CR, BAYA1040) 40 mg OD | ACTIVE_COMPARATOR | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning |
| Nifedipine (Adalat CR, BAYA1040) 40 mg BID | EXPERIMENTAL | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening |
| Nifedipine (Adalat CR, BAYA1040) 80 mg OD | EXPERIMENTAL | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning |
| Name | Type | Description |
|---|---|---|
| Nifedipine (Adalat CR, BAYA1040) 80mg OD | DRUG | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning |
| Nifedipine (Adalat CR, BAYA1040) 40mg BID | DRUG | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening |
| Nifedipine (Adalat CR, BAYA1040) 40mg OD | DRUG | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning |
Inclusion Criteria: * Male and female * 20 years or older and less than 75 years * Outpatient * Untreated or treated patients with antihypertensive agents whose blood pressure (BP) in sitting position at entry (Visit 1) is as follows. * Untreated patients: systolic blood pressure (SBP) \>= 160mm...
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 OD is being developed for the treatment of hypertension, or high blood pressure. It is an oral small molecule formulation studied in adults aged 20 years and older. Development is at Phase 2, so it is investigational and not yet an approved therapy for this indication.
Nifedipine OD targets calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker of these channels, which are voltage-gated calcium channels involved in regulating calcium entry into vascular smooth muscle and cardiac cells, producing vasodilation and reduced blood pressure.
Nifedipine OD is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the 80 mg once-daily formulation in hypertension.
Nifedipine OD is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA for hypertension. The program has one completed Phase 2 trial, and no active trials are currently listed.
Nifedipine OD has been evaluated in one completed Phase 2 trial, NCT00768560, titled Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study. It enrolled 35 adults with hypertension in Japan, was randomized, double-blind, and used an active control design.
Yes. Nifedipine OD is also known as Nifedipine (Adalat CR, BAYA1040) 80mg OD. Adalat CR and BAY A1040 are alternative names used for the same 80 mg once-daily nifedipine formulation developed by Bayer, so searches for those names refer to this asset.