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rolofyline
rolofyline is a Small molecule drug developed by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). It is currently in Phase 2 development. Also known as: MK7418.
Rolofoyline is a selective A1 adenosine receptor antagonist being studied for its potential in treating conditions such as congestive heart failure and renal impairment. It was investigated in the PROTECT-1 study, a clinical trial sponsored by NovaCardia, Inc., a subsidiary of Merck & Co., Inc.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | rolofyline |
|---|---|
| Also known as | MK7418 |
| Sponsor | NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PHASE3)
- Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients (PHASE2)
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:
- rolofyline CI brief — competitive landscape report
- rolofyline updates RSS · CI watch RSS
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) portfolio CI
Frequently asked questions about rolofyline
What is rolofyline?
Who makes rolofyline?
Is rolofyline also known as anything else?
What development phase is rolofyline in?
Related
- Manufacturer: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: MK7418
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing