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Data updated: Jun 28, 2026

ASTELLAS

Specialty
OncologyMetabolicImmunology Execution: Good

ASTELLAS is a specialty pharmaceutical company focused on Oncology, Metabolic, Immunology. Key products include XTANDI.

1957
Since
23
Drugs
-
Trials
1
New Drugs (2yr)
Modality:
9 Small Molecules

FDA Novel Drug Designations

(2018-2024)
5 Novel 3 First-in-Class 2 Orphan 2 Breakthrough 1 Accelerated 4 Priority Review 3 Fast Track
See 5 novel approvals →
2024 VYLOY (ZOLBETUXIMAB-CLZB) First-in-Class · Orphan · Priority Review · Fast Track
2023 VEOZAH (FEZOLINETANT) First-in-Class
2023 IZERVAY (AVACINCAPTAD PEGOL SODIUM) Breakthrough · Priority Review · Fast Track
2019 PADCEV (ENFORTUMAB VEDOTIN-EJFV) First-in-Class · Breakthrough · Priority Review · Accelerated
2018 XOSPATA (GILTERITINIB FUMARATE) Orphan · Priority Review · Fast Track

ASTELLAS at a Glance

  • Fast trial execution (18 months median completion)

ASTELLAS's Recent FDA Approvals

ASTELLAS secured 1 new FDA approval for novel drugs (NDA/BLA) in the last two years.

VYLOY BLA
2024-10-18
zolbetuximab-clzb
Gastric Adenocarcinoma

ASTELLAS's Therapeutic Areas

ASTELLAS's approved drugs and pipeline span 5 therapeutic areas, led by Oncology and Metabolic, across 0 biologic and 9 small-molecule drugs. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Oncology 51%
3 drugs Phase 3: 18 Phase 2: 31 Phase 1: 79
Metabolic 19%
0 drugs Phase 3: 15 Phase 2: 8 Phase 1: 11
Immunology 15%
0 drugs Phase 3: 10 Phase 2: 10 Phase 1: 10
Gastroenterology 9%
1 drugs Phase 3: 4 Phase 2: 3 Phase 1: 12
Infectious Disease 6%
2 drugs Phase 3: 2 Phase 2: 2 Phase 1: 2

ASTELLAS Pipeline Snapshot

ASTELLAS has 217 active clinical programs from ClinicalTrials.gov — 49 Phase 3, 54 Phase 2 and 114 Phase 1.

49
Phase 3
54
Phase 2
114
Phase 1

Phase 3 Readout Calendar Pro

7 Phase 3 trials with confidence-graded primary completion dates.

Full calendar →
Q4 2027
Roxadustat
Chronic Kidney Disease
Estimated · fresh NCT05970172
Q3 2028
zolbetuximab
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Estimated · fresh NCT06901531
Q3 2029
Setidegrasib
Pancreatic Cancer
Estimated · fresh NCT07409272
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • • XTANDI leads revenue
  • • 5 key drugs tracked
View revenue breakdown →

Trial Catalysts

  • • Oncology pipeline focus
  • • 7 Phase 3 readouts tracked
View readout calendar →

Patent Risk

  • • Patent expiration timeline
  • • Revenue at risk analysis
View patent timeline →

Compare Companies

  • • Side-by-side pipeline analysis
  • • Revenue & market share comparison
Compare with competitor →

Execution Intelligence

  • • Phase 3: 4/5 completed
  • • Speed: 18 months avg
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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