Last reviewed 2026-04-20 · How we verify

Spasmalgan (DENAVERINE)

Phase 2 active Small molecule

Spasmalgan (generic name: DENAVERINE) is a denaverine drug. It is currently in Phase 2 development.

Denaverine works by blocking calcium channels in muscle cells, reducing muscle spasms.

Spasmalgan, also known as Denaverine, is a small molecule drug in the denaverine class. Its exact target is unknown, but it is used to treat muscle spasms. The commercial status of Spasmalgan is unclear, and it may be patented or have generic manufacturers. Key safety considerations include its long half-life of 34.0 hours, although its bioavailability is unknown. Further research is needed to fully understand its pharmacology and clinical use.

Likelihood of approval

15.3% 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).

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	DENAVERINE
Drug class	denaverine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your muscle cells have special doors that let calcium in, which makes them contract. Denaverine blocks these doors, so less calcium gets in and the muscle relaxes. This helps to reduce muscle spasms and cramps.

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:

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

Frequently asked questions about Spasmalgan

What is Spasmalgan?

Spasmalgan (DENAVERINE) is a denaverine drug.

How does Spasmalgan work?

Denaverine works by blocking calcium channels in muscle cells, reducing muscle spasms.

What is the generic name of Spasmalgan?

DENAVERINE is the generic (nonproprietary) name of Spasmalgan.

What drug class is Spasmalgan in?

Spasmalgan belongs to the denaverine class. See all denaverine drugs at /class/denaverine.

What development phase is Spasmalgan in?

Spasmalgan is in Phase 2.

Drug class: All denaverine drugs
Therapeutic area: All drugs in Other

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