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PINAVERIUM
PINAVERIUM is a pinaverium drug. It is currently in Phase 2 development.
PINAVERIUM works by relaxing smooth muscle in the gastrointestinal tract, reducing spasms and cramping.
PINAVERIUM is a small molecule with the chemical name pinaverium bromide, used as an intervention in clinical trials for conditions such as Bile Duct Diseases, Sphincter of Oddi Dysfunction, and Irritable Bowel Syndrome. It has been studied in combination with other interventions, including Vitamin C and Danshu Capsules, in clinical trials such as NCT02882451.
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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).
| 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 | PINAVERIUM |
|---|---|
| Drug class | pinaverium |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 2 |
Mechanism of action
Imagine your digestive tract as a muscular tube that moves food through your body. PINAVERIUM helps calm down the muscles in this tube, making it easier for food to pass through and reducing discomfort.
Approved indications
Common side effects
- Heart sounds
- Prolonged expiration
- Depressive symptom
- Respiration abnormal
- Appetite disorder
- Sleep disorder due to a general medical condition
- Flank pain
- Rales
- Stress
- Rhinorrhoea
- Depressed mood
- Angina pectoris
Key clinical trials
- Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS (NA)
- Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP) (NA)
- Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (PHASE2,PHASE3)
- Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography (NA)
- Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST) (NA)
- Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction (PHASE4)
- Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose) (PHASE4)
- A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome (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:
- PINAVERIUM CI brief — competitive landscape report
- PINAVERIUM updates RSS · CI watch RSS
Frequently asked questions about PINAVERIUM
What is PINAVERIUM?
How does PINAVERIUM work?
What drug class is PINAVERIUM in?
What development phase is PINAVERIUM in?
What are the side effects of PINAVERIUM?
Related
- Drug class: All pinaverium drugs
- Therapeutic area: All drugs in Gastroenterology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing