Clinical Trials

Dipivefrin Hydrochloride has been evaluated in a clinical trial investigating its therapeutic potential in severe allergic conditions, including food allergy, food hypersensitivity, peanut allergy, and systemic anaphylaxis. In an open-label, early-phase clinical trial sponsored by Insignis Therapeutics, Inc., investigators assessed the safety, tolerability, and clinical pharmacokinetics of an L-dipivefrin derivative following single-dose administration. Having completed recruitment, the study generated early-stage human safety profiles essential for evaluating the compound's utility in emergency allergic management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07210320 COMPLETED
Food Allergy; Anaphylaxis; Food Hypersensitivity; Food Allergy Peanut
Insignis Therapeutics, Inc.
 2025-10-24 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dipivefrin Hydrochloride functions as a lipophilic prodrug that undergoes enzymatic cleavage by esterases to yield epinephrine, which directly stimulates alpha- and beta-adrenergic receptors. This receptor activation modulates intracellular cyclic AMP signaling to promote vasoconstriction and bronchial smooth muscle relaxation, mitigating acute physiological responses associated with severe food allergies and anaphylaxis.

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>).

Jump to

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