NDARECTALENEMAPriority Review
Approved
Jan 1966
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
CORTENEMA (hydrocortisone) by ANI Pharmaceuticals is corticosteroid hormone receptor agonists [moa]. First approved in 1966.
Drug data last refreshed 1h ago · AI intelligence enriched 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTENEMA is a rectal enema formulation of hydrocortisone, a corticosteroid that works by agonizing corticosteroid hormone receptors to reduce inflammation. It is indicated for inflammatory bowel conditions affecting the colon and rectum. The product has been on the market since 1966 and represents a well-established, mature therapy in gastroenterology.
$0.007BPart D
LOE ApproachingLimited growth opportunity in a legacy product with minimal Part D claims; brand team likely focused on lifecycle extension and cost management rather than expansion.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)
Started Sep 2025
400 enrolled
Pancreas Head CancerPancreas AdenocarcinomaIPMN, Pancreatic+7 more
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Started Jun 2025
26 enrolled
Hematopoietic and Lymphatic System Neoplasm
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
Started Oct 2022
180 enrolled
Healthcare-Associated PneumoniaVentilator Associated Pneumonia
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Started May 2022
55 enrolled
Congenital Adrenal Hyperplasia
Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction
Started Nov 2021
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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.