Last reviewed 2026-04-20 · How we verify

Smedolin (ETOMIDOLINE)

Phase 2 active Small molecule

Smedolin (generic name: ETOMIDOLINE) is a etomidoline drug. It is currently in Phase 2 development.

Smedolin works by interacting with specific receptors in the body to produce its effects.

Smedolin, also known as etomidoline, is a small molecule drug in the etomidoline class. Its exact target and mechanism of action are unknown, but it is believed to work by interacting with specific receptors in the body. Smedolin's commercial status and approved indications are unclear, and it is not known whether it is patented or available as a generic medication. Further research is needed to fully understand its effects and potential uses. As a result, key safety considerations and pharmacokinetic properties, such as half-life and bioavailability, are also unknown.

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	ETOMIDOLINE
Drug class	etomidoline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Smedolin is a key that fits into those locks. When it binds to the locks, it sends a signal that can affect how your body works. This can help to treat certain conditions, but more research is needed to understand exactly how it works and what effects it has 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:

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

Frequently asked questions about Smedolin

What is Smedolin?

Smedolin (ETOMIDOLINE) is a etomidoline drug.

How does Smedolin work?

Smedolin works by interacting with specific receptors in the body to produce its effects.

What is the generic name of Smedolin?

ETOMIDOLINE is the generic (nonproprietary) name of Smedolin.

What drug class is Smedolin in?

Smedolin belongs to the etomidoline class. See all etomidoline drugs at /class/etomidoline.

What development phase is Smedolin in?

Smedolin is in Phase 2.

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

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