Last reviewed · How we verify

Hexanium (HEXAMETHONIUM)

Phase 2 active Small molecule

Hexanium (generic name: HEXAMETHONIUM) is a hexamethonium drug. It is currently in Phase 2 development.

Hexamethonium works by blocking the action of acetylcholine at nicotinic receptors in the autonomic nervous system.

Hexamethonium, also known as Hexanium, is a small molecule drug that targets the neuronal acetylcholine receptor subunit alpha-4. It belongs to the hexamethonium class and is used to treat conditions related to the autonomic nervous system. However, there is limited information available on its commercial status, approved indications, and pharmacokinetic properties. Further research is needed to determine its potential as a therapeutic agent. As a result, its current status in the pharmaceutical market is unclear.

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 nameHEXAMETHONIUM
Drug classhexamethonium
TargetNeuronal acetylcholine receptor subunit alpha-6, Neuronal acetylcholine receptor subunit alpha-4, Neuronal acetylcholine receptor; alpha4/beta2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of acetylcholine as a key that unlocks a door in the nervous system. Hexamethonium is like a lock that prevents the key from turning, effectively blocking the signal that can cause certain bodily functions to occur. This can help to reduce symptoms associated with conditions such as hypertension and certain types of arrhythmias.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Hexanium

What is Hexanium?

Hexanium (HEXAMETHONIUM) is a hexamethonium drug.

How does Hexanium work?

Hexamethonium works by blocking the action of acetylcholine at nicotinic receptors in the autonomic nervous system.

What is the generic name of Hexanium?

HEXAMETHONIUM is the generic (nonproprietary) name of Hexanium.

What drug class is Hexanium in?

Hexanium belongs to the hexamethonium class. See all hexamethonium drugs at /class/hexamethonium.

What development phase is Hexanium in?

Hexanium is in Phase 2.

What does Hexanium target?

Hexanium targets Neuronal acetylcholine receptor subunit alpha-6, Neuronal acetylcholine receptor subunit alpha-4, Neuronal acetylcholine receptor; alpha4/beta2 and is a hexamethonium.

Related

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