Last reviewed 2026-05-28 · How we verify

Ortoxine (METHOXYPHENAMINE)

Phase 2 active Small molecule ✓ Verified May 2026

Ortoxine (generic name: METHOXYPHENAMINE) is a methoxyphenamine drug. It is currently in Phase 2 development.

Ortoxine works by interacting with specific biological targets to produce a therapeutic effect.

Ortoxine is a small molecule with the synonyms METHOXYPHENAMINE, METHOXYPHENAMINE, and METOXIFENAMINA.

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	METHOXYPHENAMINE
Drug class	methoxyphenamine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2
Annual revenue	172

Mechanism of action

Imagine Ortoxine as a key that unlocks a specific lock in the body, allowing it to work properly. However, the exact lock and how it works are still not fully understood. More research is needed to determine the precise mechanism of action.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial (PHASE1,PHASE2)

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
SEC EDGAR	Revenue + earnings

Competitive intelligence

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

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

Frequently asked questions about Ortoxine

What is Ortoxine?

Ortoxine (METHOXYPHENAMINE) is a methoxyphenamine drug.

How does Ortoxine work?

Ortoxine works by interacting with specific biological targets to produce a therapeutic effect.

What is the generic name of Ortoxine?

METHOXYPHENAMINE is the generic (nonproprietary) name of Ortoxine.

What drug class is Ortoxine in?

Ortoxine belongs to the methoxyphenamine class. See all methoxyphenamine drugs at /class/methoxyphenamine.

What development phase is Ortoxine in?

Ortoxine is in Phase 2.

What is Ortoxine's annual revenue?

Ortoxine generated approximately $0.0B in annual revenue.

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

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