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Protecadin (LAFUTIDINE)
Protecadin (generic name: LAFUTIDINE) is a lafutidine drug. It is currently in Phase 3 development for Gastro-esophageal reflux disease with esophagitis.
Protecadin works by blocking histamine H2 receptors to reduce stomach acid production.
Protecadin is a small molecule that acts as a histamine H2 receptor antagonist. It is classified as an antagonist and has been identified as a histamine H2 receptor antagonist.
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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 | LAFUTIDINE |
|---|---|
| Drug class | lafutidine |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Imagine your stomach lining has special receptors that tell it to make more acid when you eat. Protecadin blocks these receptors, so your stomach doesn't make as much acid, which helps to heal and protect the esophagus from damage.
Approved indications
- Gastro-esophageal reflux disease with esophagitis
Common side effects
- Platelet count decreased
- Interstitial lung disease
- White blood cell count decreased
- Neutrophil count decreased
- Febrile neutropenia
- Hepatic function abnormal
Key clinical trials
- A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients (PHASE3)
- A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet (PHASE1)
- The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers (PHASE1)
- Prophylaxis for Aspiration of Gastric Contents. (PHASE4)
- Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets (PHASE1)
- Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
- Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - (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:
- Protecadin CI brief — competitive landscape report
- Protecadin updates RSS · CI watch RSS
Frequently asked questions about Protecadin
What is Protecadin?
How does Protecadin work?
What is Protecadin used for?
What is the generic name of Protecadin?
What drug class is Protecadin in?
What development phase is Protecadin in?
What are the side effects of Protecadin?
Related
- Drug class: All lafutidine drugs
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Gastro-esophageal reflux disease with esophagitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing