Last reviewed 2026-05-26 · How we verify

Tramiprosate (3APS)

Bellus Health Inc. - a GSK company · Phase 3 active Small molecule Under review Quality 0/100

Tramiprosate (3APS) is a Amyloid-beta aggregation inhibitor Small molecule drug developed by Bellus Health Inc. - a GSK company. It is currently in Phase 3 development for Mild cognitive impairment due to Alzheimer's disease, Mild dementia due to Alzheimer's disease.

Tramiprosate inhibits amyloid-beta aggregation and promotes its clearance, reducing amyloid plaque formation in the brain.

Tramiprosate (3APS) is a small molecule that stabilizes amyloid-beta A4 protein. It has been studied in clinical trials for the treatment of Alzheimer's Disease.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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).
Big-pharma sponsor +3.0pp
Bellus Health Inc. - a GSK company 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Tramiprosate (3APS)
Sponsor	Bellus Health Inc. - a GSK company
Drug class	Amyloid-beta aggregation inhibitor
Target	Amyloid-beta (Aβ)
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Tramiprosate (3APS) is a small molecule that binds to soluble amyloid-beta peptides and prevents their polymerization into toxic aggregates. By stabilizing monomeric amyloid-beta and promoting its clearance from the central nervous system, it aims to slow cognitive decline in Alzheimer's disease. The drug targets the pathological hallmark of Alzheimer's disease—amyloid plaque accumulation—rather than downstream inflammatory or tau-related pathways.

Approved indications

Mild cognitive impairment due to Alzheimer's disease
Mild dementia due to Alzheimer's disease

Common side effects

Meningoencephalitis
Amyloid-related imaging abnormalities (ARIA)
Headache
Infusion reactions

Key clinical trials

Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease (PHASE3)

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:

Tramiprosate (3APS) CI brief — competitive landscape report
Tramiprosate (3APS) updates RSS · CI watch RSS
Bellus Health Inc. - a GSK company portfolio CI

Frequently asked questions about Tramiprosate (3APS)

What is Tramiprosate (3APS)?

Tramiprosate (3APS) is a Amyloid-beta aggregation inhibitor drug developed by Bellus Health Inc. - a GSK company, indicated for Mild cognitive impairment due to Alzheimer's disease, Mild dementia due to Alzheimer's disease.

How does Tramiprosate (3APS) work?

Tramiprosate inhibits amyloid-beta aggregation and promotes its clearance, reducing amyloid plaque formation in the brain.

What is Tramiprosate (3APS) used for?

Tramiprosate (3APS) is indicated for Mild cognitive impairment due to Alzheimer's disease, Mild dementia due to Alzheimer's disease.

Who makes Tramiprosate (3APS)?

Tramiprosate (3APS) is developed by Bellus Health Inc. - a GSK company (see full Bellus Health Inc. - a GSK company pipeline at /company/bellus-health-inc-a-gsk-company).

What drug class is Tramiprosate (3APS) in?

Tramiprosate (3APS) belongs to the Amyloid-beta aggregation inhibitor class. See all Amyloid-beta aggregation inhibitor drugs at /class/amyloid-beta-aggregation-inhibitor.

What development phase is Tramiprosate (3APS) in?

Tramiprosate (3APS) is in Phase 3.

What are the side effects of Tramiprosate (3APS)?

Common side effects of Tramiprosate (3APS) include Meningoencephalitis, Amyloid-related imaging abnormalities (ARIA), Headache, Infusion reactions.

What does Tramiprosate (3APS) target?

Tramiprosate (3APS) targets Amyloid-beta (Aβ) and is a Amyloid-beta aggregation inhibitor.

Drug class: All Amyloid-beta aggregation inhibitor drugs
Target: All drugs targeting Amyloid-beta (Aβ)
Manufacturer: Bellus Health Inc. - a GSK company — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Mild cognitive impairment due to Alzheimer's disease
Indication: Drugs for Mild dementia due to Alzheimer's disease

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