Clinical Trials

The clinical landscape for Olcegepant includes a clinical trial sponsored by Boehringer Ingelheim focused on early-phase human safety evaluation. This completed, double-blind, placebo-controlled Phase 1 study investigated intravenous administration to assess safety, tolerability, and preliminary pharmacokinetics in healthy male and female volunteers. Consequently, documented clinical research on Olcegepant remains centered on establishing baseline safety and tolerability parameters in healthy human subjects.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02198352 Completed
Healthy
Boehringer Ingelheim
 1998-06 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olcegepant acts as a potent, highly selective non-peptide antagonist of the calcitonin gene-related peptide 1 (CGRP1) receptor, binding to the receptor complex to competitively inhibit CGRP-mediated intracellular cyclic AMP generation and downstream vasodilation cascade activation. By suppressing neurogenic vascular relaxation and CGRP signaling pathways, this targeted blockade mediates cranial vasoconstrictive signaling responses, providing the mechanistic rationale for evaluating its safety and tolerability in Phase 1 trials involving healthy human subjects.

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.