NDAORALSOLUTION
Approved
May 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
KHINDIVI (hydrocortisone) by PharmaIN is corticosteroid hormone receptor agonists [moa]. First approved in 2025.
Drug data last refreshed 17h ago · AI intelligence enriched 4w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KHINDIVI is an oral hydrocortisone solution approved May 2025, a corticosteroid hormone receptor agonist used to treat adrenal insufficiency and other corticosteroid-responsive conditions. It works by binding glucocorticoid receptors to reduce inflammation and modulate immune function. This is a new chemical entity formulation of a well-established active pharmaceutical ingredient.
Growth16.3 years to LOE
Early-stage growth product with no competitive pressure signals strong market opportunity for commercial build-out and team 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)
Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma
Started Sep 2026
59 enrolled
Non-hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Mantle Cell Lymphoma+2 more
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
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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.