Last reviewed 2026-04-20 · How we verify

Kalgut (DENOPAMINE)

Phase 2 active Small molecule

Kalgut (generic name: DENOPAMINE) is a denopamine drug. It is currently in Phase 2 development.

Denopamine works by stimulating the beta-1 adrenergic receptor, which increases heart rate and contractility.

Kalgut, also known as denopamine, is a small molecule drug that targets the beta-1 adrenergic receptor. It is a denopamine drug class, but its commercial status and approved indications are unknown. The mechanism of action involves stimulating the beta-1 adrenergic receptor, which can increase heart rate and contractility. As a result, it may be used to treat heart failure or other cardiovascular conditions. However, its safety and efficacy have not been established through FDA approval.

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	DENOPAMINE
Drug class	denopamine
Target	Solute carrier family 22 member 1, Beta-1 adrenergic receptor
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks a lock on your heart. When denopamine binds to the beta-1 adrenergic receptor, it sends a signal that tells your heart to beat faster and stronger. This can help improve heart function and increase blood flow to the body.

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:

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

Frequently asked questions about Kalgut

What is Kalgut?

Kalgut (DENOPAMINE) is a denopamine drug.

How does Kalgut work?

Denopamine works by stimulating the beta-1 adrenergic receptor, which increases heart rate and contractility.

What is the generic name of Kalgut?

DENOPAMINE is the generic (nonproprietary) name of Kalgut.

What drug class is Kalgut in?

Kalgut belongs to the denopamine class. See all denopamine drugs at /class/denopamine.

What development phase is Kalgut in?

Kalgut is in Phase 2.

What does Kalgut target?

Kalgut targets Solute carrier family 22 member 1, Beta-1 adrenergic receptor and is a denopamine.

Drug class: All denopamine drugs
Target: All drugs targeting Solute carrier family 22 member 1, Beta-1 adrenergic receptor
Therapeutic area: All drugs in Cardiovascular

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