Last reviewed 2026-05-26 · How we verify

Emidone (HYDROXYPETHIDINE)

Phase 2 active Small molecule ✓ Verified May 2026

Emidone (generic name: HYDROXYPETHIDINE) is a hydroxypethidine drug. It is currently in Phase 2 development.

Emidone is a small molecule that works by interacting with an unknown target in the body.

Emidone is a small molecule with synonyms including BEMIDONE, BIPHENAL, DEMIDONE, and others. Its exact mechanism and indications are not specified in the provided information from ChEMBL.

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	HYDROXYPETHIDINE
Drug class	hydroxypethidine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Unfortunately, we don't know exactly how Emidone works, but it's thought to affect the way certain chemicals in the brain communicate with each other. This can influence various bodily functions, but the specifics are still unclear. More research is needed to understand its effects on the body.

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:

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

Frequently asked questions about Emidone

What is Emidone?

Emidone (HYDROXYPETHIDINE) is a hydroxypethidine drug.

How does Emidone work?

Emidone is a small molecule that works by interacting with an unknown target in the body.

What is the generic name of Emidone?

HYDROXYPETHIDINE is the generic (nonproprietary) name of Emidone.

What drug class is Emidone in?

Emidone belongs to the hydroxypethidine class. See all hydroxypethidine drugs at /class/hydroxypethidine.

What development phase is Emidone in?

Emidone is in Phase 2.

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

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