Last reviewed 2026-04-19 · How we verify

OXETORONE

Phase 2 active Small molecule

OXETORONE is a oxetorone drug. It is currently in Phase 2 development for Migraine.

Oxetorone is thought to work by modulating the activity of certain neurotransmitters involved in pain transmission.

Oxetorone is a small molecule drug in the oxetorone class, originally developed by an unknown entity and currently owned by an unknown entity. It is used to treat migraine, but its exact target is unknown. The commercial status of oxetorone is unclear, as it is unknown whether it is patented or available as a generic medication. Key safety considerations for oxetorone are not well-documented. Further research is needed to fully understand the pharmacology and safety profile of this medication.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	OXETORONE
Drug class	oxetorone
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain has a messaging system that helps you feel pain. Oxetorone is believed to help regulate this system by influencing the chemicals that carry pain messages. This can help reduce the severity of migraine headaches.

Approved indications

Migraine

Common side effects

Polycythaemia

Key clinical trials

Interest of Relaxation From Patients With Pain Due to Migraine (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about OXETORONE

What is OXETORONE?

OXETORONE is a oxetorone drug, indicated for Migraine.

How does OXETORONE work?

Oxetorone is thought to work by modulating the activity of certain neurotransmitters involved in pain transmission.

What is OXETORONE used for?

OXETORONE is indicated for Migraine.

What drug class is OXETORONE in?

OXETORONE belongs to the oxetorone class. See all oxetorone drugs at /class/oxetorone.

What development phase is OXETORONE in?

OXETORONE is in Phase 2.

What are the side effects of OXETORONE?

Common side effects of OXETORONE include Polycythaemia.

Drug class: All oxetorone drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Migraine

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