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 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYLERAN (busulfan) is an oral alkylating agent used primarily in hematologic malignancies and as a conditioning agent before hematopoietic stem cell transplantation. It works by forming covalent bonds with DNA, disrupting cell replication and leading to cell death. The drug has been a foundational therapy in oncology for nearly 70 years.
$0.092MPart D
LOE ApproachingMinimal commercial momentum with only 15 Part D claims in 2023; team size likely small and focused on maintenance rather than growth initiatives.
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.