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Data updated: Jun 28, 2026

KYOWA KIRIN

Biotech
OncologyMetabolicNeurology Execution: Excellent

KYOWA KIRIN is a biotechnology company focused on Oncology, Metabolic, Neurology. Key products include NOURIANZ.

1997
Since
4
Drugs
-
Trials
0
New Drugs (2yr)
Modality:
1 Small Molecules

FDA Novel Drug Designations

(2018-2019)
3 Novel 3 First-in-Class 2 Orphan 2 Breakthrough 2 Priority Review 1 Fast Track
See 3 novel approvals →
2019 NOURIANZ (ISTRADEFYLLINE) First-in-Class
2018 POTELIGEO (MOGAMULIZUMAB-KPKC) First-in-Class · Orphan · Breakthrough · Priority Review
2018 CRYSVITA (BUROSUMAB-TWZA) First-in-Class · Orphan · Breakthrough · Priority Review · Fast Track

KYOWA KIRIN at a Glance

  • Strong track record with 84% execution quality across 135 trials
  • Fast trial execution (20 months median completion)

KYOWA KIRIN's Key Drugs

KYOWA KIRIN's core commercial portfolio centers on POTELIGEO, CRYSVITA, NOURIANZ, spanning Oncology and Metabolic — its most strategically important drugs approved in the last 15 years.

POTELIGEO
Oncology

Mycosis Fungoides

CCR4 Approved 2018
CRYSVITA
Rare Disease

X-Linked Hypophosphatemia

FGF23 Approved 2018
NOURIANZ
CNS

Parkinson's Disease

Adenosine A2A receptor Approved 2019

KYOWA KIRIN's Recent FDA Approvals

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

No recent approvals

KYOWA KIRIN's Therapeutic Areas

KYOWA KIRIN's approved drugs and pipeline span 5 therapeutic areas, led by Oncology and Metabolic, across 0 biologic and 1 small-molecule drug. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Oncology 40%
1 drugs Phase 3: 8 Phase 2: 14 Phase 1: 31
Metabolic 22%
0 drugs Phase 3: 9 Phase 2: 7 Phase 1: 3
Neurology 19%
1 drugs Phase 3: 7 Phase 2: 2 Phase 1: 8
Immunology 15%
0 drugs Phase 3: 7 Phase 2: 2 Phase 1: 5
Gastroenterology 3%
0 drugs Phase 2: 2 Phase 1: 4

KYOWA KIRIN Pipeline Snapshot

KYOWA KIRIN has 109 active clinical programs from ClinicalTrials.gov — 31 Phase 3, 27 Phase 2 and 51 Phase 1.

31
Phase 3
27
Phase 2
51
Phase 1

Phase 3 Readout Calendar Pro

1 Phase 3 trial with confidence-graded primary completion dates.

Full calendar →
Q2 2029
KK8398
Achondroplasia
Estimated · stale NCT06926491

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

  • • POTELIGEO leads revenue
  • • 3 key drugs tracked

Trial Catalysts

  • • Oncology pipeline focus
  • • 1 Phase 3 readout tracked
View readout calendar →

Patent Risk

  • • Patent expiration timeline
  • • Revenue at risk analysis

Compare Companies

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

Execution Intelligence

  • • Phase 3: 35/40 completed
  • • Speed: 20 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