Last reviewed 2026-05-25 · How we verify

Amidalgon (DIOXAPHETYL BUTYRATE)

Phase 2 active Small molecule

Amidalgon (generic name: DIOXAPHETYL BUTYRATE) is a drug. It is currently in Phase 2 development.

Amidalgon is thought to work by interacting with specific biological pathways, but the exact mechanism is unknown.

Amidalgon, also known as DIOXAPHETYL BUTYRATE, is a small molecule compound with unknown target and drug class. Its commercial status and approved indications are currently unavailable. As a small molecule, it is likely to interact with specific biological pathways, but the exact mechanism of action is unknown. Further research is needed to determine its potential therapeutic applications and safety profile. The compound's 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	DIOXAPHETYL BUTYRATE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a complex orchestra, with many different instruments working together to create a harmonious whole. Amidalgon is like a new instrument that's been added to the orchestra, but we don't yet know how it fits in or what it does. As researchers learn more about how it works, they may be able to use it to help treat certain diseases or conditions.

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:

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

Frequently asked questions about Amidalgon

What is Amidalgon?

Amidalgon (DIOXAPHETYL BUTYRATE) is a Small molecule drug.

How does Amidalgon work?

Amidalgon is thought to work by interacting with specific biological pathways, but the exact mechanism is unknown.

What is the generic name of Amidalgon?

DIOXAPHETYL BUTYRATE is the generic (nonproprietary) name of Amidalgon.

What development phase is Amidalgon in?

Amidalgon is in Phase 2.

Therapeutic area: All drugs in Other

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