Last reviewed 2026-04-20 · How we verify

Isadanone (ISOMETHADONE)

Phase 2 active Small molecule

Isadanone (generic name: ISOMETHADONE) is a isomethadone drug. It is currently in Phase 2 development.

Isadanone is believed to work by interacting with opioid receptors in the brain.

Isadanone, also known as Isomethadone, is a small molecule drug in the isomethadone class. Its exact target and mechanism of action are unknown, but it is believed to work by interacting with opioid receptors in the brain. Isadanone is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Key safety considerations for Isadanone are not well established due to its lack of FDA approval. Further research is needed to fully understand the properties and potential risks of this medication.

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	ISOMETHADONE
Drug class	isomethadone
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your brain has special locks that control pain and feelings of well-being. Isadanone is thought to fit into these locks, which can help reduce pain and other symptoms. However, this process can also have unintended consequences, such as dependence or side effects.

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:

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

Frequently asked questions about Isadanone

What is Isadanone?

Isadanone (ISOMETHADONE) is a isomethadone drug.

How does Isadanone work?

Isadanone is believed to work by interacting with opioid receptors in the brain.

What is the generic name of Isadanone?

ISOMETHADONE is the generic (nonproprietary) name of Isadanone.

What drug class is Isadanone in?

Isadanone belongs to the isomethadone class. See all isomethadone drugs at /class/isomethadone.

What development phase is Isadanone in?

Isadanone is in Phase 2.

Drug class: All isomethadone drugs
Therapeutic area: All drugs in Pain

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