Last reviewed 2026-05-24 · How we verify

DIOXADROL

Phase 2 active Small molecule ✓ Verified May 2026

DIOXADROL is a dioxadrol drug. It is currently in Phase 2 development.

DIOXADROL is a small molecule that works by interacting with a specific target, although the exact target and mechanism are unknown.

Dioxadrol is a small molecule with the synonyms CL-639C, DIOXADROL HCL, DIOXADROL HYDROCHLORIDE, DIOXADROL HYDROCHLORIDE, NSC-70774, and RYDAR. However, no specific information is available on its clinical indications or mechanism of action.

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	DIOXADROL
Drug class	dioxadrol
Target	Sigma non-opioid intracellular receptor 1
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and DIOXADROL is a key that fits into one of those locks. When it binds, it can affect how the cell works, but without knowing the target, it's hard to say exactly how. This is a simplified explanation, and the actual mechanism is likely much more complex.

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:

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

Frequently asked questions about DIOXADROL

What is DIOXADROL?

DIOXADROL is a dioxadrol drug.

How does DIOXADROL work?

DIOXADROL is a small molecule that works by interacting with a specific target, although the exact target and mechanism are unknown.

What drug class is DIOXADROL in?

DIOXADROL belongs to the dioxadrol class. See all dioxadrol drugs at /class/dioxadrol.

What development phase is DIOXADROL in?

DIOXADROL is in Phase 2.

What does DIOXADROL target?

DIOXADROL targets Sigma non-opioid intracellular receptor 1 and is a dioxadrol.

Drug class: All dioxadrol drugs
Target: All drugs targeting Sigma non-opioid intracellular receptor 1
Therapeutic area: All drugs in Pain

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