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(+/-)-Eperisone (EPERISONE)
(+/-)-Eperisone (generic name: EPERISONE) is a eperisone drug. It is currently in Phase 3 development for Spasm.
Eperisone works by binding to the Sigma non-opioid intracellular receptor 1, which helps to reduce muscle spasms.
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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).
| 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 | EPERISONE |
|---|---|
| Drug class | eperisone |
| Target | Sigma non-opioid intracellular receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Imagine your muscles are like a bunch of excited kids in a playground. When they get overexcited, they start to spasm and get stiff. Eperisone helps calm them down by binding to a specific receptor that tells the muscles to relax.
Approved indications
- Spasm
Common side effects
- Hepatic function abnormal
- Hypokalaemia
- Spinal compression fracture
- Renal impairment
- Renal tubular acidosis
Key clinical trials
- Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain (NA)
- Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus (NA)
- Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203 (PHASE1)
- A Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of DW340 in Patients With Acute Low Back Pain (PHASE2)
- Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients (PHASE3)
- Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg (PHASE1)
- A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10) (NA)
- Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial (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:
- (+/-)-Eperisone CI brief — competitive landscape report
- (+/-)-Eperisone updates RSS · CI watch RSS
Frequently asked questions about (+/-)-Eperisone
What is (+/-)-Eperisone?
How does (+/-)-Eperisone work?
What is (+/-)-Eperisone used for?
What is the generic name of (+/-)-Eperisone?
What drug class is (+/-)-Eperisone in?
What development phase is (+/-)-Eperisone in?
What are the side effects of (+/-)-Eperisone?
What does (+/-)-Eperisone target?
Related
- Drug class: All eperisone drugs
- Target: All drugs targeting Sigma non-opioid intracellular receptor 1
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Spasm
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing