Last reviewed 2026-05-24 · How we verify

PRIDINOL

Phase 2 active Small molecule ✓ Verified May 2026

PRIDINOL is a pridinol drug. It is currently in Phase 2 development.

Pridinol works by binding to the muscarinic acetylcholine receptor M1, which helps to relax muscles and reduce muscle spasms.

Pridinol is a small molecule drug used in the treatment of conditions such as spondyloarthropathy, specifically lumbar spondylarthrosis and chronic low back pain. It is administered through drug therapy, often in conjunction with rehabilitation.

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 name	PRIDINOL
Drug class	pridinol
Target	Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M3
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your muscles have a 'brake' that helps them relax. Pridinol works by activating this 'brake', which helps to reduce muscle spasms and pain. This can be especially helpful for people with conditions like muscle cramps or spasms.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain (NA)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial 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:

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

Frequently asked questions about PRIDINOL

What is PRIDINOL?

PRIDINOL is a pridinol drug.

How does PRIDINOL work?

Pridinol works by binding to the muscarinic acetylcholine receptor M1, which helps to relax muscles and reduce muscle spasms.

What drug class is PRIDINOL in?

PRIDINOL belongs to the pridinol class. See all pridinol drugs at /class/pridinol.

What development phase is PRIDINOL in?

PRIDINOL is in Phase 2.

What does PRIDINOL target?

PRIDINOL targets Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M3 and is a pridinol.

Drug class: All pridinol drugs
Target: All drugs targeting Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2, Muscarinic acetylcholine receptor M3
Therapeutic area: All drugs in Neuroscience

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