Last reviewed 2026-05-27 · How we verify

Thiocolchicoside+Ketoprofen

Sanofi · Phase 3 active Small molecule Under review

Thiocolchicoside+Ketoprofen is a Muscle relaxant + NSAID combination Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Acute musculoskeletal pain and spasticity, Muscle contractures and spasticity associated with neurological conditions.

Thiocolchicoside reduces muscle spasticity through GABA-A receptor modulation, while ketoprofen inhibits cyclooxygenase enzymes to reduce inflammation and pain.

Thiocolchicoside+Ketoprofen is a fixed combination of two small molecule compounds used to treat acute non-specific low back pain. It is a small molecule modality that has been studied for its efficacy and safety in clinical trials, specifically for low back pain.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Thiocolchicoside+Ketoprofen
Sponsor	Sanofi
Drug class	Muscle relaxant + NSAID combination
Target	GABA-A receptor (thiocolchicoside); COX-1/COX-2 (ketoprofen)
Modality	Small molecule
Therapeutic area	Musculoskeletal/Pain Management
Phase	Phase 3

Mechanism of action

Thiocolchicoside is a semi-synthetic derivative of colchicoside that acts as a muscle relaxant by enhancing GABAergic neurotransmission in the central nervous system, thereby reducing muscle tone and spasticity. Ketoprofen is a non-selective NSAID that inhibits COX-1 and COX-2, reducing prostaglandin synthesis and thereby decreasing inflammation, pain, and fever. The combination provides complementary analgesic and anti-inflammatory effects for musculoskeletal conditions.

Approved indications

Acute musculoskeletal pain and spasticity
Muscle contractures and spasticity associated with neurological conditions

Common side effects

Gastrointestinal disturbances (nausea, dyspepsia)
Dizziness
Headache
Abdominal pain
Drowsiness

Key clinical trials

Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain (PHASE3)

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:

Thiocolchicoside+Ketoprofen CI brief — competitive landscape report
Thiocolchicoside+Ketoprofen updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about Thiocolchicoside+Ketoprofen

What is Thiocolchicoside+Ketoprofen?

Thiocolchicoside+Ketoprofen is a Muscle relaxant + NSAID combination drug developed by Sanofi, indicated for Acute musculoskeletal pain and spasticity, Muscle contractures and spasticity associated with neurological conditions.

How does Thiocolchicoside+Ketoprofen work?

Thiocolchicoside reduces muscle spasticity through GABA-A receptor modulation, while ketoprofen inhibits cyclooxygenase enzymes to reduce inflammation and pain.

What is Thiocolchicoside+Ketoprofen used for?

Thiocolchicoside+Ketoprofen is indicated for Acute musculoskeletal pain and spasticity, Muscle contractures and spasticity associated with neurological conditions.

Who makes Thiocolchicoside+Ketoprofen?

Thiocolchicoside+Ketoprofen is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

What drug class is Thiocolchicoside+Ketoprofen in?

Thiocolchicoside+Ketoprofen belongs to the Muscle relaxant + NSAID combination class. See all Muscle relaxant + NSAID combination drugs at /class/muscle-relaxant-nsaid-combination.

What development phase is Thiocolchicoside+Ketoprofen in?

Thiocolchicoside+Ketoprofen is in Phase 3.

What are the side effects of Thiocolchicoside+Ketoprofen?

Common side effects of Thiocolchicoside+Ketoprofen include Gastrointestinal disturbances (nausea, dyspepsia), Dizziness, Headache, Abdominal pain, Drowsiness.

What does Thiocolchicoside+Ketoprofen target?

Thiocolchicoside+Ketoprofen targets GABA-A receptor (thiocolchicoside); COX-1/COX-2 (ketoprofen) and is a Muscle relaxant + NSAID combination.

Drug class: All Muscle relaxant + NSAID combination drugs
Target: All drugs targeting GABA-A receptor (thiocolchicoside); COX-1/COX-2 (ketoprofen)
Manufacturer: Sanofi — full pipeline
Therapeutic area: All drugs in Musculoskeletal/Pain Management
Indication: Drugs for Acute musculoskeletal pain and spasticity
Indication: Drugs for Muscle contractures and spasticity associated with neurological conditions

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