Clinical Trials

Multiple clinical trials evaluate the therapeutic and pharmacokinetic profiles of 9-cis-retinoic acid across oncology, metabolic, infectious, and hepatic conditions, including breast cancer, low HDL cholesterol, tuberculosis, and hepatic insufficiency. Sponsored by academic medical centers, university hospitals, and government entities such as the National Cancer Institute, these Phase 1 through Phase 3 studies range in recruitment status from completed to unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05077813 UNKNOWN
Tuberculosis
Kafrelsheikh University
 2021-12 PHASE2
NCT05016349 UNKNOWN
Breast Cancer Female
Mahmoud Ramadan mohamed Elkazzaz
 2021-08 PHASE3
NCT01261923 COMPLETED
Hepatic Insufficiency
University Hospital, Gentofte, Copenhagen
 2010-12 PHASE1; PHASE2
NCT00156169 COMPLETED
Low HDL Cholesterol
Sheba Medical Center
 2001-05 PHASE3
NCT00001504 COMPLETED
Breast Cancer; Breast Neoplasm
National Cancer Institute (NCI)
 1996-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2021-10-14)

Check the 9-cis-Retinoic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

9-cis-Retinoic acid functions as a high-affinity ligand that binds and activates retinoid X receptors (RXRs) and retinoic acid receptors (RARs), downregulating RXRα and PPARγ expression to inhibit adipogenesis and cellular proliferation. This transcriptional regulation of nuclear receptor pathways provides the mechanistic rationale for its clinical evaluation in conditions such as breast cancer.

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.