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Methylatropinium (METHYLATROPINE)

Phase 2 active Small molecule ✓ Verified May 2026

Methylatropinium (generic name: METHYLATROPINE) is a methylatropine drug. It is currently in Phase 2 development.

Methylatropinium works by blocking the action of acetylcholine, a neurotransmitter that helps transmit signals in the nervous system.

Methylatropinium is a small molecule with the synonyms 8-METHYLATROPINIUM NITRATE, ATROPINE METHONITRATE, and others.

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 nameMETHYLATROPINE
Drug classmethylatropine
TargetMuscarinic acetylcholine receptor DM1, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of acetylcholine like a messenger that helps different parts of the body communicate with each other. When methylatropinium blocks this messenger, it can affect various bodily functions, such as muscle contractions, heart rate, and digestion. This can be useful in treating certain conditions, but it also means that the drug can have significant side effects if not used carefully.

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:

Frequently asked questions about Methylatropinium

What is Methylatropinium?

Methylatropinium (METHYLATROPINE) is a methylatropine drug.

How does Methylatropinium work?

Methylatropinium works by blocking the action of acetylcholine, a neurotransmitter that helps transmit signals in the nervous system.

What is the generic name of Methylatropinium?

METHYLATROPINE is the generic (nonproprietary) name of Methylatropinium.

What drug class is Methylatropinium in?

Methylatropinium belongs to the methylatropine class. See all methylatropine drugs at /class/methylatropine.

What development phase is Methylatropinium in?

Methylatropinium is in Phase 2.

What does Methylatropinium target?

Methylatropinium targets Muscarinic acetylcholine receptor DM1, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2 and is a methylatropine.

Related

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