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Nepresol (DIHYDRALAZINE)
Nepresol (generic name: DIHYDRALAZINE) is a dihydralazine drug. It is currently in Phase 3 development.
Nepresol works by relaxing blood vessels and reducing blood pressure.
Nepresol, also known as dihydralazine, is a small molecule drug in the dihydralazine class. Its exact target and mechanism of action are unknown, but it is used to treat certain cardiovascular conditions. The commercial status of Nepresol is unclear, and it may be patented or available as a generic medication. Key safety considerations for Nepresol are not well-documented. Further research is needed to fully understand its pharmacology and clinical use.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DIHYDRALAZINE |
|---|---|
| Drug class | dihydralazine |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Imagine your blood vessels are like roads in your body. When they're narrow, it's harder for blood to flow through them. Nepresol helps to widen these roads, making it easier for blood to flow and reducing the pressure inside your blood vessels.
Approved indications
Common side effects
- Patent ductus arteriosus
- Shone complex
- Ventricular septal defect
- Product prescribing error
- Foetal exposure during pregnancy
- Atrial septal defect
- Supravalvular aortic stenosis
- Aorta hypoplasia
- Language disorder
- Premature baby
- Pulmonary valve stenosis congenital
Key clinical trials
- Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden (PHASE3)
- The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nepresol CI brief — competitive landscape report
- Nepresol updates RSS · CI watch RSS
Frequently asked questions about Nepresol
What is Nepresol?
How does Nepresol work?
What is the generic name of Nepresol?
What drug class is Nepresol in?
What development phase is Nepresol in?
What are the side effects of Nepresol?
Related
- Drug class: All dihydralazine drugs
- Therapeutic area: All drugs in Hematology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing