Last reviewed · How we verify
Placebo enteric-coated tablet
Placebo enteric-coated tablet is a Small molecule drug developed by POLYSAN Scientific & Technological Pharmaceutical Company. It is currently in Phase 3 development for Treatment of symptoms associated with irritable bowel syndrome. Also known as: povidone, calcium stearate, hypromellose, polysorban, dyes.
Placebo enteric-coated tablets are used in clinical trials to study various conditions, including osteoarthritis of the thumb, epilepsy, and coronary heart disease. The enteric coating is derived from the husks of the Indian plantain seed, also known as ispaghula husks.
-
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 | Placebo enteric-coated tablet |
|---|---|
| Also known as | povidone, calcium stearate, hypromellose, polysorban, dyes |
| Sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
- Treatment of symptoms associated with irritable bowel syndrome
Common side effects
- Nausea
- Abdominal pain
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Efavirenz for the Treatment of Creutzfeldt-Jakob Disease (PHASE3)
- COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (PHASE3)
- Evaluation of the Outcome of Fecal Microbiota Transplantation (PHASE1, PHASE2)
- Aspirin for Prevention of Stroke After Endovascular Aortic Arch Repair: a Multicenter, Double-Blind, Randomized Controlled Trial (EARLY_PHASE1)
- Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia (PHASE4)
- Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia (PHASE4)
- Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT) (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:
- Placebo enteric-coated tablet CI brief — competitive landscape report
- Placebo enteric-coated tablet updates RSS · CI watch RSS
- POLYSAN Scientific & Technological Pharmaceutical Company portfolio CI
Frequently asked questions about Placebo enteric-coated tablet
What is Placebo enteric-coated tablet?
What is Placebo enteric-coated tablet used for?
Who makes Placebo enteric-coated tablet?
Is Placebo enteric-coated tablet also known as anything else?
What development phase is Placebo enteric-coated tablet in?
What are the side effects of Placebo enteric-coated tablet?
Related
- Manufacturer: POLYSAN Scientific & Technological Pharmaceutical Company — full pipeline
- Indication: Drugs for Treatment of symptoms associated with irritable bowel syndrome
- Also known as: povidone, calcium stearate, hypromellose, polysorban, dyes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing