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Data updated: Jun 28, 2026
NIPPON SHINYAKU
Pharma Pharmaceuticals
NIPPON SHINYAKU is a pharmaceutical company with 1 FDA-approved products.
2020
Since
1
Drugs
-
Trials
0
New Drugs (2yr)
Modality:
1 Small Molecules
FDA Novel Drug Designations
(2020) 1 Novel 1 Orphan 1 Accelerated 1 Priority Review 1 Fast Track
See 1 novel approval →
2020 VILTEPSO (VILTOLARSEN) Orphan · Priority Review · Accelerated · Fast Track
NIPPON SHINYAKU's Key Drugs
NIPPON SHINYAKU's core commercial portfolio centers on VILTEPSO — its most strategically important drugs approved in the last 15 years.
NIPPON SHINYAKU's Recent FDA Approvals
New NDA/BLA approvals for NIPPON SHINYAKU over the last two years — novel drugs only, excluding generics and label supplements.
No recent approvals
NIPPON SHINYAKU's Therapeutic Areas
Disease areas where NIPPON SHINYAKU has approved drugs and an active pipeline. Weighted by commercial stage — approved drugs count most, then late-stage trials.
No indication data
NIPPON SHINYAKU Pipeline Snapshot
Active clinical trials for NIPPON SHINYAKU across all therapeutic areas, from ClinicalTrials.gov.
No active pipeline data available
Pro Expected Approvals & Milestones
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Revenue Insights
- • VILTEPSO leads revenue
- • Drug-level revenue analysis
Trial Catalysts
- • Active trial monitoring
- • Phase 3 readout tracking
Patent Risk
- • Patent expiration timeline
- • Revenue at risk analysis
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- • Revenue & market share comparison
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Active (1)
Discontinued (0)
Company Info
- First Approval
- 2020-08-12
- Latest
- 2021-03-11
- Applications
- 1