Last reviewed 2026-04-20 · How we verify

Calbogen (HEXCARBACHOLINE)

Phase 2 active Small molecule

Calbogen (generic name: HEXCARBACHOLINE) is a hexcarbacholine drug. It is currently in Phase 2 development.

Calbogen works by stimulating the parasympathetic nervous system, which helps to regulate various bodily functions such as heart rate and digestion.

Calbogen, also known as hexcarbacholine, is a small molecule drug in the hexcarbacholine class. Its exact target and mechanism of action are unknown, but it is believed to work by stimulating the parasympathetic nervous system. Calbogen's commercial status and approved indications are unclear, and it is not known whether it is patented or available as a generic. Further research is needed to fully understand its safety profile and potential therapeutic applications. As a result, it is not currently available for use in clinical settings.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	HEXCARBACHOLINE
Drug class	hexcarbacholine
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of the parasympathetic nervous system like the 'brake' in your body's 'car'. When it's stimulated, it helps to slow down your heart rate, calm your digestive system, and promote relaxation. This can be helpful in certain medical conditions, but more research is needed to understand its full effects.

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:

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

Frequently asked questions about Calbogen

What is Calbogen?

Calbogen (HEXCARBACHOLINE) is a hexcarbacholine drug.

How does Calbogen work?

Calbogen works by stimulating the parasympathetic nervous system, which helps to regulate various bodily functions such as heart rate and digestion.

What is the generic name of Calbogen?

HEXCARBACHOLINE is the generic (nonproprietary) name of Calbogen.

What drug class is Calbogen in?

Calbogen belongs to the hexcarbacholine class. See all hexcarbacholine drugs at /class/hexcarbacholine.

What development phase is Calbogen in?

Calbogen is in Phase 2.

Drug class: All hexcarbacholine drugs
Therapeutic area: All drugs in Cardiovascular

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