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 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
THIOPLEX (thiotepa) is an alkylating agent administered by injection used in oncology and hematology settings. It functions by cross-linking DNA to inhibit cell proliferation, making it effective in treating certain cancers and as a conditioning agent for bone marrow transplantation. This small molecule has a long clinical history dating back decades.
LOE Approaching
LOE-approaching injectable with minimal commercial momentum; expect contracting team size and focus on value defense 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
Working on THIOPLEX offers limited growth upside; career trajectory will be defensive with emphasis on market access and managed care expertise. This is a mature product role suitable for specialists in LOE management rather than high-visibility commercial launches.
Field Sales
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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.