NDAINTRAVENOUSSOLUTION
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
4/8 — Partial
TEPYLUTE (thiotepa) by Gland Pharma is alkylating activity [moa]. First approved in 2024.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEPYLUTE (thiotepa) is an intravenous alkylating agent approved in June 2024 by Gland Pharma for cancer treatment. It works by forming covalent bonds with DNA, disrupting cell replication and inducing apoptosis in malignant cells. The drug represents a formulation innovation in a well-established mechanism class.
Growth15.2 years to LOE
Early-stage commercial ramp with 15.2 years of exclusivity support; brand team is actively building market presence in a non-crowded space.
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 (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
Career Relevance
TEPYLUTE offers early-career exposure to a newly approved oncology product with minimal competitive pressure and a 15-year exclusivity horizon. Professionals joining now will shape market positioning, reimbursement strategy, and indication expansion in a growth-phase product.
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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.