NDAINTRAVENOUSPOWDER
Approved
Jan 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
4/8 — Partial
TEPADINA AND SODIUM CHLORIDE (thiotepa) by Adienne Pharma and Biotech is alkylating activity [moa]. First approved in 2017.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEPADINA is a thiotepa-based alkylating agent administered intravenously as a powder formulation for reconstitution. It functions through DNA alkylation to disrupt cancer cell proliferation and is primarily used in hematologic malignancies and solid tumors requiring high-dose chemotherapy. The drug targets rapidly dividing cells by forming covalent bonds with DNA, preventing replication.
Peak10.7 years to LOE
Peak-stage product with stable commercial performance; team size likely moderate with focus on market maintenance and compliance.
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
TEPADINA represents a specialized oncology opportunity within a niche but stable market segment. Career growth potential centers on market access optimization, indication expansion, and long-term commercial management rather than high-volume launch activities.
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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.