Last reviewed 2026-06-02 · How we verify

Nicergoline from China

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

Nicergoline from China is a Small molecule drug developed by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. It is currently in Phase 1 development.

Nicergoline is a small molecule medication from China, used in a bioequivalence study to compare its pharmacokinetics with Nicergoline from Italy in healthy Chinese participants. The study, NCT04176367, aimed to evaluate the equivalence of Nicergoline 10 mg tablets manufactured in China and Italy under fasted and fed conditions.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	Nicergoline from China
Sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants (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:

Nicergoline from China CI brief — competitive landscape report
Nicergoline from China updates RSS · CI watch RSS
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. portfolio CI

Frequently asked questions about Nicergoline from China

What is Nicergoline from China?

Nicergoline from China is a Small molecule drug developed by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Who makes Nicergoline from China?

Nicergoline from China is developed by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (see full Pfizer's Upjohn has merged with Mylan to form Viatris Inc. pipeline at /company/pfizer-s-upjohn-has-merged-with-mylan-to-form-viatris-inc).

What development phase is Nicergoline from China in?

Nicergoline from China is in Phase 1.

Manufacturer: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full pipeline

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