NDASUBCUTANEOUSEMULSION
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
CAMCEVI ETM (leuprolide mesylate) by Accord Biopharma. Approved for prostate cancer, central precocious puberty. First approved in 2025.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMCEVI (leuprolide mesylate) is a GnRH agonist delivered as a subcutaneous emulsion for treatment of advanced prostate cancer and central precocious puberty. It suppresses testosterone production by acting on the hypothalamic-pituitary-gonadal axis, slowing disease progression in hormone-sensitive cancers and arresting early puberty development.
Launch2.3 years to LOE
Recent FDA approval positions this as an emerging product; team size and market penetration depend on Accord's commercial execution against entrenched AR-inhibitor competitors.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (2)
Clinical Trials (3)
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
Started Jun 2023
93 enrolled
Puberty; Precocious, Central
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
Started Sep 2017
144 enrolled
Prostatic Neoplasms
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
Started Aug 2014
137 enrolled
Prostatic Neoplasms
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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.