Last reviewed 2026-04-19 · How we verify

Linaprazan Glurate Capsules

Jiangsu Sinorda Biomedicine Co., Ltd · Phase 1 active Small molecule

Linaprazan Glurate Capsules is a Small molecule drug developed by Jiangsu Sinorda Biomedicine Co., Ltd. It is currently in Phase 1 development. Also known as: Linaprazan Glurate.

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	Linaprazan Glurate Capsules
Also known as	Linaprazan Glurate
Sponsor	Jiangsu Sinorda Biomedicine Co., Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

Linaprazan Glurate Capsules CI brief — competitive landscape report
Linaprazan Glurate Capsules updates RSS · CI watch RSS
Jiangsu Sinorda Biomedicine Co., Ltd portfolio CI

Frequently asked questions about Linaprazan Glurate Capsules

What is Linaprazan Glurate Capsules?

Linaprazan Glurate Capsules is a Small molecule drug developed by Jiangsu Sinorda Biomedicine Co., Ltd.

Who makes Linaprazan Glurate Capsules?

Linaprazan Glurate Capsules is developed by Jiangsu Sinorda Biomedicine Co., Ltd (see full Jiangsu Sinorda Biomedicine Co., Ltd pipeline at /company/jiangsu-sinorda-biomedicine-co-ltd).

Is Linaprazan Glurate Capsules also known as anything else?

Linaprazan Glurate Capsules is also known as Linaprazan Glurate.

What development phase is Linaprazan Glurate Capsules in?

Linaprazan Glurate Capsules is in Phase 1.

Manufacturer: Jiangsu Sinorda Biomedicine Co., Ltd — full pipeline
Also known as: Linaprazan Glurate

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