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Nipolazin (MEQUITAZINE)

Phase 2 active Small molecule

Nipolazin (generic name: MEQUITAZINE) is a mequitazine drug. It is currently in Phase 2 development.

Mequitazine works by blocking the action of acetylcholine at the muscarinic acetylcholine receptor M3.

Nipolazin, also known as mequitazine, is a small molecule drug that targets the muscarinic acetylcholine receptor M3. It belongs to the mequitazine class and works by blocking the action of acetylcholine at this receptor, which is involved in various physiological processes. Mequitazine is used to treat allergic conditions, but its exact indications and commercial status are unknown. As a result, its half-life, bioavailability, and generic manufacturers are also unclear. Further research is needed to determine its full potential and safety profile.

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 nameMEQUITAZINE
Drug classmequitazine
TargetHistamine H1 receptor, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your body has a system of messengers, called neurotransmitters, that help different parts work together. Acetylcholine is one of these messengers that helps control things like heart rate and breathing. Mequitazine blocks the action of acetylcholine at the M3 receptor, which can help reduce symptoms of allergic conditions.

Approved indications

No approved indications tracked.

Common side effects

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 Nipolazin

What is Nipolazin?

Nipolazin (MEQUITAZINE) is a mequitazine drug.

How does Nipolazin work?

Mequitazine works by blocking the action of acetylcholine at the muscarinic acetylcholine receptor M3.

What is the generic name of Nipolazin?

MEQUITAZINE is the generic (nonproprietary) name of Nipolazin.

What drug class is Nipolazin in?

Nipolazin belongs to the mequitazine class. See all mequitazine drugs at /class/mequitazine.

What development phase is Nipolazin in?

Nipolazin is in Phase 2.

What are the side effects of Nipolazin?

Common side effects of Nipolazin include Tubulointerstitial nephritis and uveitis syndrome.

What does Nipolazin target?

Nipolazin targets Histamine H1 receptor, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2 and is a mequitazine.

Related

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