Clinical Trials

Relacorilant has been evaluated in numerous clinical trials across Phase I to Phase III for endocrine disorders and oncological indications, including Cushing syndrome, hypercortisolism, adrenocortical carcinoma, gynecological malignancies, pancreatic ductal carcinoma, and solid tumors. Sponsored by industry entities such as Corcept Therapeutics alongside research organizations including the ARCAGY/GINECO Group and the University of Chicago, trial statuses range from completed pharmacokinetic evaluations to active or recruiting combination therapy protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07763496 NOT_YET_RECRUITING
Recurrent or Metastatic Cervical Cancer
ARCAGY/ GINECO GROUP
 2026-10 PHASE2
NCT05726292 RECRUITING
Prostate Cancer; Prostate Adenocarcinoma
University of Chicago
 2025-01-06 PHASE2
NCT07259317 RECRUITING
Adenocarcinoma; Carcinoma, Pancreatic Ductal
Corcept Therapeutics
 2026-01-27 PHASE2
NCT03604198 ACTIVE_NOT_RECRUITING
Cushing Syndrome
Corcept Therapeutics
 2018-05-07 PHASE2
NCT06906341 RECRUITING
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms; Endometrial Cancer
Corcept Therapeutics
 2025-04-11 PHASE2
NCT05257408 ACTIVE_NOT_RECRUITING
Ovarian Neoplasm; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Corcept Therapeutics
 2022-06-29 PHASE3
NCT04308590 COMPLETED
Hypercortisolism
Corcept Therapeutics
 2020-07-27 PHASE3
NCT03674814 COMPLETED
Prostate Cancer
University of Chicago
 2018-10-23 PHASE1
NCT03697109 COMPLETED
Cushing Syndrome
Corcept Therapeutics
 2018-11-15 PHASE3
NCT04373265 COMPLETED
Adrenocortical Carcinoma
Corcept Therapeutics
 2020-09-30 PHASE1
NCT05347979 COMPLETED
Cushing Syndrome; Neoplasms
Corcept Therapeutics
 2022-05-25 PHASE1
NCT05347979 Completed
Cushing Syndrome|Neoplasms
Corcept Therapeutics
 2022-05-25 Phase 1
NCT04329949 TERMINATED
Metastatic Pancreatic Ductal Adenocarcinoma
Corcept Therapeutics
 2020-06-30 PHASE3
NCT04795479 COMPLETED
Healthy
Corcept Therapeutics
 2021-01-22 PHASE1
NCT03776812 COMPLETED
Recurrent Ovarian Cancer; Recurrent Fallopian Tube Carcinoma; Recurrent Primary Peritoneal Carcinoma
Corcept Therapeutics
 2019-04-05 PHASE2
NCT06094725 COMPLETED
Hepatic Impairment
Corcept Therapeutics
 2020-01-06 PHASE1
NCT06094738 COMPLETED
Healthy
Corcept Therapeutics
 2020-09-19 PHASE1
NCT04373265 Completed
Adrenocortical Carcinoma
Corcept Therapeutics
 2020-09-30 Phase 1
NCT04308590 Recruiting
Hypercortisolism
Corcept Therapeutics
 2020-07-27 Phase 3
NCT02762981 COMPLETED
Solid Tumors
Corcept Therapeutics
 2016-05-23 PHASE1; PHASE2
NCT03512548 COMPLETED
Healthy
Corcept Therapeutics
 2018-04-10 PHASE1
NCT03540836 COMPLETED
Healthy
Corcept Therapeutics
 2018-05-24 PHASE1
NCT03457597 COMPLETED
Healthy
Corcept Therapeutics
 2018-03-06 PHASE1
NCT03442621 COMPLETED
Healthy; Food-drug Interaction
Corcept Therapeutics
 2018-01-16 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Relacorilant (CORT125134) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Relacorilant acts as a potent, selective antagonist of the glucocorticoid receptor, binding the receptor to competitively inhibit agonist-driven transcriptional activation and downstream receptor signaling cascades. This molecular blockade downregulates anti-apoptotic pathways and suppresses cortisol-mediated cellular responses, mitigating hormonal excess and potentiating cytotoxic antineoplastic regimens in clinical indications such as Cushing syndrome, hypercortisolism, adrenocortical carcinoma, and solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.