NDASUBCUTANEOUSEMULSION
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
CAMCEVI KIT (leuprolide) by Accord Biopharma is leuprolide, a gnrh agonist, acts as an inhibitor of gonadotropin secretion. First approved in 2021.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMCEVI KIT is a subcutaneous emulsion formulation of leuprolide, a GnRH agonist approved in May 2021 by Accord Biopharma. It suppresses gonadotropin secretion, leading to reversible inhibition of ovarian and testicular steroidogenesis. The product is indicated for patients requiring gonadal hormone suppression, with primary uses in advanced prostate cancer and hormone-responsive conditions.
Peak12.5 years to LOE
Product is at peak lifecycle stage with stable commercial performance; brand teams should focus on market penetration and indication expansion to sustain revenue growth.
Mechanism of Action
Leuprolide, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal and human studies indicate that following an initial stimulation of gonadotropins, chronic administration of leuprolide results in suppression of ovarian and testicular steroidogenesis. This effect is reversible upon…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Started Jan 2025
72 enrolled
Recurrent Prostate CarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Started Aug 2024
70 enrolled
Prostate AdenocarcinomaStage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
Started Jun 2023
93 enrolled
Puberty; Precocious, Central
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
80 enrolled
Central Precocious Puberty
Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis
Started Mar 2022
16 enrolled
Endometriosis
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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.