Clinical Trials

Several clinical trials evaluate 7-Hydroxycarbostyril across diverse conditions, including gynecologic malignancies (such as Lynch syndrome and uterine corpus carcinoma), clavicle fractures, chronic pain, and psychiatric disorders. Featuring unassigned or non-applicable phases, these studies are currently listed as suspended or not yet recruiting. Sponsoring entities encompass academic and governmental organizations, including the National Cancer Institute, the Gynecologic Oncology Group Foundation, and academic research institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT05454306 Suspended
Clavicle Fracture
University of Minnesota
2028-01-09 Not Applicable
NCT05118594 Not yet recruiting
Major Depressive Disorder|Dysthymic Disorder|Specific Phobia|Social Anxiety Disorder|Panic Disorder|Agoraphobia|Generalized Anxiety Disorder
National Council of Scientific and Technical Research Argentina
2026-02 Not Applicable
NCT06077526 Not yet recruiting
Chronic Pain
Bridgewater College
2026-01-13 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the 7-Hydroxycarbostyril product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

7-Hydroxycarbostyril engages cellular receptor and enzymatic targets to block downstream biochemical signaling pathways, thereby inhibiting pathological cellular activity and cell proliferation. This target-mediated suppression prevents dysfunctional signaling cascades, providing potential clinical relevance for investigating conditions such as uterine corpus carcinoma, chronic pain, and major depressive disorder.

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>).

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