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Omeprazole Pill
Omeprazole Pill is a Small molecule drug developed by SK Life Science, Inc.. It is currently in Phase 1 development.
Omeprazole is a medication used to treat conditions such as Gastroesophageal Reflux and Dyspepsia, as well as other conditions including Cystic Fibrosis, Obesity, and Nausea. It works by inhibiting the proton pump in the stomach, a mechanism of action that is shared with other proton pump inhibitors like Esomeprazole and Nexium.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Omeprazole Pill |
|---|---|
| Sponsor | SK Life Science, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans (PHASE3)
- Esomeprazole and Radiation Induced Esophagitis (PHASE2)
- Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy (PHASE2)
- A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range (PHASE1)
- Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females As Compared with Males (PHASE4)
- Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions (PHASE1)
- The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication (PHASE4)
- Biomarkers for Prediction of Analgesic Efficacy in Knee OA. (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:
- Omeprazole Pill CI brief — competitive landscape report
- Omeprazole Pill updates RSS · CI watch RSS
- SK Life Science, Inc. portfolio CI
Frequently asked questions about Omeprazole Pill
What is Omeprazole Pill?
Who makes Omeprazole Pill?
What development phase is Omeprazole Pill in?
Related
- Manufacturer: SK Life Science, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing