Last reviewed 2026-05-22 · How we verify

Stomopral

Genuine Research Center, Egypt · Phase 1 active Small molecule ✓ Verified May 2026

Stomopral is a Small molecule drug developed by Genuine Research Center, Egypt. It is currently in Phase 1 development. Also known as: Nexium.

Stomopral is a medication used in a bioequivalence study to compare its effects with Nexium, another medication. The study, conducted by the Genuine Research Center in Egypt, investigated the bioequivalence of Stomopral 40 mg capsules with Nexium 40 mg delayed release capsules in healthy individuals.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Stomopral
Also known as	Nexium
Sponsor	Genuine Research Center, Egypt
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) (PHASE1)

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:

Stomopral CI brief — competitive landscape report
Stomopral updates RSS · CI watch RSS
Genuine Research Center, Egypt portfolio CI

Frequently asked questions about Stomopral

What is Stomopral?

Stomopral is a Small molecule drug developed by Genuine Research Center, Egypt.

Who makes Stomopral?

Stomopral is developed by Genuine Research Center, Egypt (see full Genuine Research Center, Egypt pipeline at /company/genuine-research-center-egypt).

Is Stomopral also known as anything else?

Stomopral is also known as Nexium.

What development phase is Stomopral in?

Stomopral is in Phase 1.

Manufacturer: Genuine Research Center, Egypt — full pipeline
Therapeutic area: All drugs in Other
Also known as: Nexium

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing