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 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEPYLUTE (thiotepa) is an intravenous alkylating agent approved by the FDA in June 2024 as a formulation innovation by Gland Pharma. It works through alkylating activity to disrupt cancer cell DNA. The drug treats hematologic malignancies and solid tumors where alkylating chemotherapy is indicated.
Growth14.9 years to LOE
Early-stage product in growth phase with no established Medicare spending; commercial teams are building formulary access and physician adoption strategies in a nascent market.
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 represents an early-stage growth opportunity with minimal linked job postings at launch, suggesting an emerging career ladder at Gland Pharma's oncology division. Roles will focus on physician education, formulary placement, and clinical support as the product gains market traction over the next 5–10 years.
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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.