Last reviewed 2026-05-20 · How we verify

Meksibel

Vitebsk State Medical University · Phase 1 active Small molecule ✓ Verified May 2026

Meksibel is a Small molecule drug developed by Vitebsk State Medical University. It is currently in Phase 1 development.

Meksibel is being studied as a potential intervention for the prevention of acute pancreatitis after endoscopic interventions. It has also been investigated for its potential use in treating cholangiolitis and acute pancreatitis.

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	Meksibel
Sponsor	Vitebsk State Medical University
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

Prevention of Acute Pancreatitis After Endoscopic Interventions (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:

Meksibel CI brief — competitive landscape report
Meksibel updates RSS · CI watch RSS
Vitebsk State Medical University portfolio CI

Frequently asked questions about Meksibel

What is Meksibel?

Meksibel is a Small molecule drug developed by Vitebsk State Medical University.

Who makes Meksibel?

Meksibel is developed by Vitebsk State Medical University (see full Vitebsk State Medical University pipeline at /company/vitebsk-state-medical-university).

What development phase is Meksibel in?

Meksibel is in Phase 1.

Manufacturer: Vitebsk State Medical University — full pipeline
Therapeutic area: All drugs in Other

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