Last reviewed 2026-04-20 · How we verify

Galantamine 8mg

Yale University · Phase 1 active Small molecule Quality 0/100

Galantamine 8mg is a Small molecule drug developed by Yale University. It is currently in Phase 1 development. Also known as: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl.

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	Galantamine 8mg
Also known as	Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl
Sponsor	Yale University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Depression
Fatigue
Nausea

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Galantamine 8mg CI brief — competitive landscape report
Galantamine 8mg updates RSS · CI watch RSS
Yale University portfolio CI

Frequently asked questions about Galantamine 8mg

What is Galantamine 8mg?

Galantamine 8mg is a Small molecule drug developed by Yale University.

Who makes Galantamine 8mg?

Galantamine 8mg is developed by Yale University (see full Yale University pipeline at /company/yale-university).

Is Galantamine 8mg also known as anything else?

Galantamine 8mg is also known as Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl.

What development phase is Galantamine 8mg in?

Galantamine 8mg is in Phase 1.

What are the side effects of Galantamine 8mg?

Common side effects of Galantamine 8mg include Depression, Fatigue, Nausea.

Manufacturer: Yale University — full pipeline
Also known as: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl

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