TheraRadar
Data updated: May 26, 2026

CRYSVITA (burosumab-twza)

Trial Activity: Declining
First-in-Class Orphan Drug Breakthrough Therapy Priority Review Fast Track
Rare Disease Approved 2018-04-17

CRYSVITA is indicated for the treatment of X-Linked Hypophosphatemia; Tumor-Induced Osteomalacia.

Source: FDA Label • KYOWA KIRIN
Jump to: Indications Approvals Trials Competitors Safety Patents

How CRYSVITA Works

Burosumab-twza binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23). In these conditions, excess FGF23 suppresses the kidneys' ability to reabsorb phosphate and produce 1,25 dihydroxy vitamin D. By blocking FGF23, the drug restores renal phosphate reabsorption and increases the serum concentration of 1,25 dihydroxy vitamin D.

Source: FDA Label

Development Insights

Kyowa Kirin, Inc. conducting 6 trials (55%)
8 indications explored (Moderate)
→ x-linked hypophosphatemia (7 trials)
→ fibrous dysplasia of bone (1 trials)
→ x-linked hypophosphatemia (xlh) (1 trials)
4
Indications
--
Phase 3 Trials
2
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2018-04-17
Patent Cliff
2026

Pro Metrics

Patent cliff and revenue data

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Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

KYOWA KIRIN
Active Ingredient: BUROSUMAB-TWZA

CRYSVITA Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2018 to 2026 · 3 indication expansions
Apr 2026 SUPPL
Efficacy
FDA Letter Label
Aug 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2020 SUPPL Priority
Efficacy
FDA Letter Label

What CRYSVITA Treats

2 indications

CRYSVITA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • X-Linked Hypophosphatemia
  • Tumor-Induced Osteomalacia
Source: FDA Label
📋

Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT05509595 results posted 10000798 000798-D Ph 2 completed Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
NCT04188964 BUR-CL207 Ph 1, Ph 2 completed Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
NCT02915705 results posted UX023-CL301 Ph 3 completed Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
NCT02537431 results posted UX023-CL304 Ph 3 completed Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
NCT02526160 results posted UX023-CL303 2014-005529-11 Ph 3 completed Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
NCT02163577 results posted UX023-CL201 Ph 2 completed Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
NCT02750618 results posted UX023-CL205 Ph 2 completed Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
NCT02304367 results posted UX023T-CL201 Ph 2 completed Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)
NCT04695860 BurGER BUR03 Ph 3 completed Anti-FGF23 (Burosumab) in Adult Patients With XLH
NCT03920072 BUR02 Ph 3 completed Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
NCT03581591 ENSKRN23.1 Ph 3 completed Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CRYSVITA FDA Label Details

Indications & Usage

FDA Label (PDF)

CRYSVITA is indicated for the treatment of X-Linked Hypophosphatemia; Tumor-Induced Osteomalacia.

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2 patents · 2 families · 90 international docs across 25 countries

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Data Sources

FDA Approval: BLA761068 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment