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Lanzoprazole
Lanzoprazole is a Small molecule drug developed by Novartis. It is currently in Phase 3 development.
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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). -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Lanzoprazole |
|---|---|
| Sponsor | Novartis |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors) (PHASE4)
- PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy (PHASE3)
- The Effect of Proton Pump Inhibition on Palpitations (PHASE4)
- The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes (PHASE3)
- Pain Management After Cardiac Surgery - Opioids or NSAID (PHASE4)
- The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism (NA)
- Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples (NA)
- Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn (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:
- Lanzoprazole CI brief — competitive landscape report
- Lanzoprazole updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Lanzoprazole
What is Lanzoprazole?
Who makes Lanzoprazole?
What development phase is Lanzoprazole in?
Related
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing