Last reviewed 2026-05-27 · How we verify

Ro 42-5892 (REMIKIREN)

Phase 2 active Small molecule ✓ Verified May 2026

Ro 42-5892 (generic name: REMIKIREN) is a remikiren drug. It is currently in Phase 2 development.

Remikiren works by directly inhibiting the renin enzyme, which plays a key role in the renin-angiotensin-aldosterone system (RAAS) that regulates blood pressure.

Ro 42-5892 is a small molecule with the synonyms REMIKIREN, REMIKIRENE, REMIKIRENO, and others.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	REMIKIREN
Drug class	remikiren
Target	Renin
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of the RAAS like a chain reaction that helps control blood pressure. Remikiren steps in and blocks the first link in this chain, the renin enzyme, which helps to slow down the reaction and lower blood pressure. This can be beneficial for people with conditions like hypertension.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Ro 42-5892 CI brief — competitive landscape report
Ro 42-5892 updates RSS · CI watch RSS

Frequently asked questions about Ro 42-5892

What is Ro 42-5892?

Ro 42-5892 (REMIKIREN) is a remikiren drug.

How does Ro 42-5892 work?

Remikiren works by directly inhibiting the renin enzyme, which plays a key role in the renin-angiotensin-aldosterone system (RAAS) that regulates blood pressure.

What is the generic name of Ro 42-5892?

REMIKIREN is the generic (nonproprietary) name of Ro 42-5892.

What drug class is Ro 42-5892 in?

Ro 42-5892 belongs to the remikiren class. See all remikiren drugs at /class/remikiren.

What development phase is Ro 42-5892 in?

Ro 42-5892 is in Phase 2.

What does Ro 42-5892 target?

Ro 42-5892 targets Renin and is a remikiren.

Drug class: All remikiren drugs
Target: All drugs targeting Renin
Therapeutic area: All drugs in Cardiovascular

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing