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 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMCEVI KIT is a subcutaneous leuprolide emulsion approved in May 2021 by Accord Biopharma. Leuprolide is a GnRH agonist that suppresses gonadotropin secretion and testicular/ovarian steroidogenesis, with effects reversible upon discontinuation. The kit formulation represents an innovation in delivery for hormone-sensitive indications.
Peak12.3 years to LOE
CAMCEVI is in peak commercial stage with mature market penetration; brand teams focus on maintaining market share and optimizing patient access.
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
94 enrolled
Puberty; Precocious, Central
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
79 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.