Clinical Trials

Multiple clinical trials evaluate the application of hydroxyethylpiperazine ethane sulfonic acid (HEPES) in reproductive medicine and dermatology without conventional phase designations. A completed investigator-initiated trial sponsored by Muhammad Fawzy assessed the impact of HEPES-buffered media on live birth rates following intracytoplasmic sperm injection in infertile patients. Additionally, a dermatological trial sponsored by Dr. Irma Bernadette is not yet recruiting and will evaluate the efficacy of a multi-ingredient topical serum containing HEPES for managing melasma and post-acne hyperpigmentation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07121439 NOT_YET_RECRUITING
Melasma; Post-acne Hyperpigmentation
Dr.dr.Irma Bernadette, SpKK (K)
 2025-09-15
NCT03778866 COMPLETED
Infertility
Muhammad Fawzy
 2019-01-15

(data from https://clinicaltrials.gov, updated on 2025-08-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a zwitterionic chemical buffering agent maintaining physiological pH between 6.8 and 8.2, HEPES stabilizes hydrogen ion concentration and stimulates lysosomal biogenesis within target cells. This controlled pH equilibrium and cellular regulation maintain physiological homeostasis necessary for optimizing gamete viability in clinical interventions for infertility and promoting epidermal restoration in hyperpigmentation disorders.

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.