NDAORALTABLETPriority Review
Approved
Jun 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
MYLERAN (busulfan) by Viatris (2) is alkylating activity [moa]. First approved in 1954.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYLERAN (busulfan) is an oral alkylating agent used primarily as a conditioning regimen for hematopoietic stem cell transplantation and for treatment of chronic myeloid leukemia and other myeloproliferative disorders. It works by covalently binding to DNA and causing cross-linking, leading to cell death across a broad range of hematologic malignancies and immunodeficiency disorders. The drug treats 23 distinct indications ranging from leukemias and lymphomas to genetic immunodeficiency syndromes and hemoglobinopathies.
$0.092BPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Medicare Part D volume (15 claims), indicating a mature, specialized niche market with likely small commercial team.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-based Conditioning With h-ATG, Radiation, and Sirolimus
Started Nov 2025
0Severe Combined Immune Deficiency (SCID)
Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists
Started Jul 2022
50 enrolled
Chronic Granulomatous Disease
Target Busulfan Exposure in Children With HSCT in China
Started Nov 2020
500 enrolled
Hematopoietic Stem Cell Transplantation
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
Started Oct 2019
4 enrolled
Chronic Granulomatous Disease
Busulfan, Melphalan, Escalating Carfilzomib Conditioning Auto Stem Cell Transplantation for Multiple Myeloma (MM)
Started May 2019
36 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.