Last reviewed 2026-05-29 · How we verify

Orsimon (MORAZONE)

Phase 2 active Small molecule ✓ Verified May 2026

Orsimon (generic name: MORAZONE) is a morazone drug. It is currently in Phase 2 development.

Orsimon works by interacting with specific biological targets to produce its therapeutic effects.

Orsimon is a small molecule with the synonyms MORAZONA, MORAZONE, NSC-292156, and ORSIMON.

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	MORAZONE
Drug class	morazone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Orsimon is a key that fits into those locks. When it binds to the lock, it can either turn the lock (activating a cellular process) or block the lock (inhibiting a cellular process). This interaction can help to reduce inflammation or treat other conditions, but the specific details of how Orsimon works are not yet clear.

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:

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

Frequently asked questions about Orsimon

What is Orsimon?

Orsimon (MORAZONE) is a morazone drug.

How does Orsimon work?

Orsimon works by interacting with specific biological targets to produce its therapeutic effects.

What is the generic name of Orsimon?

MORAZONE is the generic (nonproprietary) name of Orsimon.

What drug class is Orsimon in?

Orsimon belongs to the morazone class. See all morazone drugs at /class/morazone.

What development phase is Orsimon in?

Orsimon is in Phase 2.

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

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