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Data updated: Jun 28, 2026

AMICUS THERAP US

Pharma
Pharmaceuticals Execution: Good

AMICUS THERAP US is a pharmaceutical company with 3 FDA-approved products.

2018
Since
3
Drugs
-
Trials
0
New Drugs (2yr)
Modality:
2 Small Molecules

FDA Novel Drug Designations

(2018-2023)
2 Novel 1 First-in-Class 2 Orphan 1 Breakthrough 1 Accelerated 1 Priority Review 1 Fast Track
See 2 novel approvals →
2023 POMBILITI (CIPAGLUCOSIDASE ALFA-ATGA) Orphan · Breakthrough
2018 GALAFOLD (MIGALASTAT HYDROCHLORIDE) First-in-Class · Orphan · Priority Review · Accelerated · Fast Track

AMICUS THERAP US at a Glance

  • Fast trial execution (23 months median completion)

AMICUS THERAP US's Key Drugs

AMICUS THERAP US's core commercial portfolio centers on POMBILITI, GALAFOLD, OPFOLDA — its most strategically important drugs approved in the last 15 years.

POMBILITI
Rare Disease

Pompe Disease

GAA Approved 2023
GALAFOLD
Rare Disease

Fabry Disease

alpha-Gal A Approved 2018
OPFOLDA
Rare Disease

Pompe Disease

Cipaglucosidase alfa-atga Approved 2023

AMICUS THERAP US's Recent FDA Approvals

New NDA/BLA approvals for AMICUS THERAP US over the last two years — novel drugs only, excluding generics and label supplements.

No recent approvals

AMICUS THERAP US's Therapeutic Areas

Disease areas where AMICUS THERAP US has approved drugs and an active pipeline. Weighted by commercial stage — approved drugs count most, then late-stage trials.

No indication data

AMICUS THERAP US Pipeline Snapshot

Active clinical trials for AMICUS THERAP US across all therapeutic areas, from ClinicalTrials.gov.

No active pipeline data available

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • • POMBILITI leads revenue
  • • 3 key drugs tracked

Trial Catalysts

  • • Active trial monitoring
  • • Phase 3 readout tracking

Patent Risk

  • • Patent expiration timeline
  • • Revenue at risk analysis

Compare Companies

  • • Side-by-side pipeline analysis
  • • Revenue & market share comparison

Execution Intelligence

  • • Phase 3: 7/12 completed
  • • Speed: 23 months avg
Unlock Full Intelligence

Revenue forecasts • Trial milestones • Patent risk modeling

How We Calculate These Metrics

Execution Quality Score

Measures trial completion rates weighted by phase importance. Phase 3 trials count 4x more than Phase 1 because late-stage completion is harder and more valuable.

What counts as "completed": A trial that reached its planned endpoint and reported results. Trials that were terminated early, withdrawn, or suspended are not counted as completed—these often indicate safety issues, lack of efficacy, or strategic pivots.

  • Excellent (80%+): Top-tier execution, most trials reach planned endpoints
  • Good (60-79%): Strong execution with occasional early terminations
  • Fair (40-59%): Average execution, notable rate of terminated/withdrawn trials
  • Needs Improvement (under 40%): High termination rates, execution challenges