Last reviewed 2026-05-21 · How we verify

Topoprazan

Genuine Research Center, Egypt · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

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

Topoprazan is a medication used in a bioequivalence study to compare its effects with Takecab, a treatment for healthy individuals. The study, conducted by the Genuine Research Center in Egypt, aimed to evaluate the equivalence of Topoprazan 20 mg tablets from Hikma Pharma with Takecab 20 mg tablets from Takeda Pharmaceutical Co. Ltd.

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	Topoprazan
Also known as	Takecab
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 Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan) (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:

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

Frequently asked questions about Topoprazan

What is Topoprazan?

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

Who makes Topoprazan?

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

Is Topoprazan also known as anything else?

Topoprazan is also known as Takecab.

What development phase is Topoprazan in?

Topoprazan is in Phase 1.

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

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