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 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
THIOPLEX (thiotepa) is an alkylating agent administered by injection that disrupts DNA function in rapidly dividing cells. It is used primarily in oncology for various malignancies and as a conditioning agent in hematopoietic stem cell transplantation. The drug's mechanism relies on covalent binding to DNA, leading to cross-linking and cell death.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100) suggests declining team investment and focus on transition planning rather than expansion.
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 offers limited career growth opportunity with zero linked job openings and declining commercial trajectory. Career value lies primarily in specialty oncology expertise, regulatory/compliance work, or transition planning as the product approaches generic competition.
Product Manager
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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.