NDAINJECTIONINJECTABLE
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
THIOPLEX (thiotepa) by Gland Pharma is alkylating activity [moa]. First approved in 1994.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
THIOPLEX (thiotepa) is a classic alkylating agent administered intravenously that works by cross-linking DNA to inhibit tumor cell proliferation and induce apoptosis. It is indicated for brain and CNS tumors, leukemia, lymphoma, myelodysplastic syndromes, and acute myeloid leukemia. The drug represents a foundational chemotherapy backbone in hematologic malignancies and CNS cancers.
LOE Approaching
As LOE approaches, the brand team will likely consolidate; expect focus on lifecycle extension strategies, generic defense, and transition planning rather than growth initiatives.
Mechanism of Action
Alkylating Activity
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
THIOPLEX roles emphasize market access, contracting, and maintenance of existing hospital/specialty oncology relationships rather than growth or launch activities. Career opportunity lies in defending market position and optimizing clinical integration as newer agents displace alkylators in treatment algorithms.
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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.