Omeprazole Drug Asset Due Diligence Report 2026

This Omeprazole Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

612

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Omeprazole can convert its Small molecule drug profile and Proton pump biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Omeprazole (query alias: omeprazole)
Modality / target	Small molecule drug; Proton pump; Proton pump inhibitors
Highest global status	Approved
Originator	AstraZeneca PLC
Active developers	Sandoz Pty Ltd., Taiyo Pharma Co., Ltd., AstraZeneca PLC

The MCP disease footprint includes Heartburn, Erosive esophagitis, Anastomotic ulcer. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT07565441	Phase 1	Not yet recruiting	112	Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
NCT07700953	Phase 1	Not yet recruiting	30	Peak concentration (Cmax)
NCT07665723	Phase 1	Recruiting	25	Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

ADJUNCT RESVERATROL OR OMEPRAZOLE IN NON-TRANSFUSION DEPENDENT THALASSEMIA PATIENTS WITH SECONDARY HEMOCHROMATOSIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Not Applicable; n=30; evaluation: Positive. Reported fields: AE = occurred in three patients receiving resveratrol (grade 1 bloating, grade 1 fatigue and grade 2 dysgeusia) and one patient receiving placebo (grade 1 bloating). All events were mild and resolved completely after treatment discontinuation. ; AE = occurred in three patients receiving resveratrol (grade 1 bloating, grade 1 fatigue and grade 2 dysgeusia) and one patient receiving placebo (grade 1 bloating). All events were mild and resolved completely after treatment discontinuation. ; AE = occurred in three patients receiving resveratrol (grade 1 bloating, grade 1 fatigue and grade 2 dysgeusia) and one patient receiving placebo (grade 1 bloating). All events were mild and resolved completely after treatment discontinuation.

A Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects

Phase 1; n=13; evaluation: not stated. Reported fields: Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 16.0 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 29.3); Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 23.5 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 33.4); Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Geometric Mean) = 19.0 nanogram (ng)*hour (h)/millilitre (mL) (Geometric Coefficient of Variation, 40.8)

An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Phase 1; n=20; evaluation: not stated. Reported fields: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib(Geometric Mean) = 28400 nanogram*hour per milliliter (ng*h/mL) (Geometric Coefficient of Variation, 20.4); -; Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib(Geometric Mean) = 26570 nanogram*hour per milliliter (ng*h/mL) (Geometric Coefficient of Variation, 14.1)

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Omeprazole addresses Heartburn, Erosive esophagitis, Anastomotic ulcer. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2019-10-01	AstraZeneca divests rights for Losec to Cheplapharm	Approved	US$243.0M upfront; US$33.0M milestones; US$276.0M stated total

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Omeprazole enteric capsule and preparation method thereof”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO