Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nurandociguat (BAY3283142) old tablet - SD, Nurandociguat old- SD, Nurandociguat (BAY3283142) new tablet - SD, Nurandociguat new- SD, Nurandociguat (BAY3283142) old tablet, Nurandociguat old, Nurandociguat (BAY3283142) new tablet, Nurandociguat new
Nurandociguat · 2 trials · 2 indications
The incidence of treatment-emergent adverse events will be summarized.
Cmax=Maximum observed concentration
AUC=Area under the concentration time curve
Cmax,md=Cmax after multiple dosing
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
| Arm | Type | Description |
|---|---|---|
| Nurandociguat Arm | EXPERIMENTAL | Participants receive nurandociguat plus 0.4 mg nitroglycerin spray |
| Placebo Arm | PLACEBO_COMPARATOR | Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray |
| Optional Scheme 1-3: Treatment A-B-C | EXPERIMENTAL | Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment A-C-B | EXPERIMENTAL | Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment B-A-C | EXPERIMENTAL | Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment B-C-A | EXPERIMENTAL | Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment C-A-B | EXPERIMENTAL | Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment C-B-A | EXPERIMENTAL | Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 4-5 | EXPERIMENTAL | Participants will receive nurandociguat new tablet for 7 days at a lower starting dose. Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days). |
| Name | Type | Description |
|---|---|---|
| Nitroglycerin spray | DRUG | 0.4 mg sublingual spray |
| Nurandociguat | DRUG | Tablet, oral |
| Placebo | DRUG | Tablet matching nurandociguat, oral |
| Nurandociguat (BAY3283142) old tablet - SD | DRUG | Single dose (SD) in treatment A. |
| Nurandociguat (BAY3283142) new tablet - SD | DRUG | Single dose (SD) in treatment B and C. |
| Nurandociguat (BAY3283142) old tablet | DRUG | High dose once daily for 5 days. |
| Nurandociguat (BAY3283142) new tablet | DRUG | Low dose once daily for 7 days, high dose once daily for 6 days. |
Inclusion Criteria: * Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent * Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 3...
Top 20 of 28 competitors
Nurandociguat is an investigational small molecule developed by Bayer AG for nephrology and cardiovascular indications. It is being studied in Phase 1 clinical trials in chronic kidney disease and stable coronary artery disease. It is not described as an approved therapy and remains in early clinical development.
Nurandociguat is being studied in chronic kidney disease to learn how a new tablet formulation is absorbed and processed in the body compared with an older tablet, and how food affects absorption of the new tablet. This work is early Phase 1 formulation and pharmacokinetic research, not a test of kidney outcomes.
Nurandociguat is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the Phase 1 studies of the drug in chronic kidney disease and stable coronary artery disease.
Nurandociguat is in Phase 1 clinical development. Its studies are early-stage trials focused on how the drug is absorbed and processed and on its safety when co-administered with nitroglycerin. The program has not advanced beyond Phase 1 based on the trials conducted to date.
Nurandociguat has been studied in NCT07722585, a completed Phase 1 trial in chronic kidney disease in Germany with 16 participants comparing an old and new tablet formulation and food effects. A second Phase 1 trial, NCT07431294, is not yet recruiting and will assess nitroglycerin safety with Nurandociguat in stable coronary artery disease across Bulgaria and Germany with 36 participants.
Yes, Nurandociguat is also known as BAY3283142. The compound appears under both names, and trial listings also distinguish formulation versions such as the old tablet and new tablet, sometimes labeled SD. Searches for BAY3283142 refer to the same investigational Bayer small molecule.