Last reviewed 2026-05-23 · How we verify

Amyvid, Intravenous Solution

Universidad Central del Caribe · Phase 2 active Small molecule ✓ Verified May 2026

Amyvid, Intravenous Solution is a PET imaging agent Small molecule drug developed by Universidad Central del Caribe. It is currently in Phase 2 development for Diagnosis of Alzheimer's disease and other neurodegenerative disorders. Also known as: Florbetapir-f18.

Amyvid is a positron emission tomography (PET) imaging agent that binds to beta-amyloid plaques in the brain.

Amyvid is an intravenous solution used in conjunction with magnetic resonance imaging (MRI) to visualize amyloid beta plaques in the brain. It is an oligosaccharide-based solution, specifically a heparin solution, and has been studied in clinical trials for conditions including Alzheimer Disease and Glioblastoma.

Likelihood of approval

12.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Amyvid, Intravenous Solution
Also known as	Florbetapir-f18
Sponsor	Universidad Central del Caribe
Drug class	PET imaging agent
Target	beta-amyloid plaques
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 2

Mechanism of action

Amyvid is a radiolabeled ligand that selectively binds to beta-amyloid plaques, allowing for visualization of amyloid burden in the brain. This can aid in the diagnosis of Alzheimer's disease and other neurodegenerative disorders.

Approved indications

Diagnosis of Alzheimer's disease and other neurodegenerative disorders

Common side effects

Injection site reaction
Nausea
Headache

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:

Amyvid, Intravenous Solution CI brief — competitive landscape report
Amyvid, Intravenous Solution updates RSS · CI watch RSS
Universidad Central del Caribe portfolio CI

Frequently asked questions about Amyvid, Intravenous Solution

What is Amyvid, Intravenous Solution?

Amyvid, Intravenous Solution is a PET imaging agent drug developed by Universidad Central del Caribe, indicated for Diagnosis of Alzheimer's disease and other neurodegenerative disorders.

How does Amyvid, Intravenous Solution work?

Amyvid is a positron emission tomography (PET) imaging agent that binds to beta-amyloid plaques in the brain.

What is Amyvid, Intravenous Solution used for?

Amyvid, Intravenous Solution is indicated for Diagnosis of Alzheimer's disease and other neurodegenerative disorders.

Who makes Amyvid, Intravenous Solution?

Amyvid, Intravenous Solution is developed by Universidad Central del Caribe (see full Universidad Central del Caribe pipeline at /company/universidad-central-del-caribe).

Is Amyvid, Intravenous Solution also known as anything else?

Amyvid, Intravenous Solution is also known as Florbetapir-f18.

What drug class is Amyvid, Intravenous Solution in?

Amyvid, Intravenous Solution belongs to the PET imaging agent class. See all PET imaging agent drugs at /class/pet-imaging-agent.

What development phase is Amyvid, Intravenous Solution in?

Amyvid, Intravenous Solution is in Phase 2.

What are the side effects of Amyvid, Intravenous Solution?

Common side effects of Amyvid, Intravenous Solution include Injection site reaction, Nausea, Headache.

What does Amyvid, Intravenous Solution target?

Amyvid, Intravenous Solution targets beta-amyloid plaques and is a PET imaging agent.

Drug class: All PET imaging agent drugs
Target: All drugs targeting beta-amyloid plaques
Manufacturer: Universidad Central del Caribe — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Diagnosis of Alzheimer's disease and other neurodegenerative disorders
Also known as: Florbetapir-f18

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