Last reviewed 2026-05-28 · How we verify

Romet (REPIRINAST)

Phase 2 active Small molecule ✓ Verified May 2026

Romet (generic name: REPIRINAST) is a repirinast drug. It is currently in Phase 2 development.

Romet works by inhibiting the activity of a specific enzyme involved in the inflammatory response.

Romet, also known as Repirinast, is a small molecule. It has multiple synonyms, including MY-5116 and Repirinast.

Likelihood of approval

15.3% 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).

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	REPIRINAST
Drug class	repirinast
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a fire alarm in a building. When there's a fire, the alarm goes off to alert people to get out. Inflammation is like a fire in the body, and the enzyme Romet targets is like the alarm that makes the fire worse. By turning off this alarm, Romet helps reduce the inflammation and its associated symptoms.

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:

Romet CI brief — competitive landscape report
Romet updates RSS · CI watch RSS

Frequently asked questions about Romet

What is Romet?

Romet (REPIRINAST) is a repirinast drug.

How does Romet work?

Romet works by inhibiting the activity of a specific enzyme involved in the inflammatory response.

What is the generic name of Romet?

REPIRINAST is the generic (nonproprietary) name of Romet.

What drug class is Romet in?

Romet belongs to the repirinast class. See all repirinast drugs at /class/repirinast.

What development phase is Romet in?

Romet is in Phase 2.

Drug class: All repirinast drugs
Therapeutic area: All drugs in Other

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