NDAINTRAVENOUSSOLUTION
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
5/8 — Partial
TEPYLUTE (thiotepa) by Gland Pharma is alkylating activity [moa]. Approved for acute myeloid leukemia. First approved in 2024.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEPYLUTE (thiotepa) is an intravenous alkylating agent approved in June 2024 for acute myeloid leukemia (AML). It works by cross-linking DNA strands, disrupting cancer cell proliferation. This is a newly approved, first-in-class formulation entering a competitive AML treatment landscape.
Growth15.3 years to LOE
Early-stage growth asset with significant market development opportunity; commercial team size will likely expand as real-world adoption increases.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications (1)
Clinical Trials (2)
Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases
Started Dec 2006
1 enrolled
Graft Versus Host DiseaseLeukemiaMyelodysplastic Syndromes
Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
Started Mar 2005
37 enrolled
Lymphoma
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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.