Eletriptan HBr Clinical Trials

Size	Price	Qty
10mg	USD 107
50mg	USD 427

Clinical Trials

A completed Phase 4 multi-center clinical trial, sponsored by pharmaceutical entities including Pfizer and Viatris Inc., evaluated oral eletriptan hydrobromide for the treatment of migraine. This post-marketing study assessed efficacy and response rates in patients presenting with mild versus moderate-to-severe headache pain intensity. The findings provide critical evidence for optimizing early intervention strategies in acute migraine management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00174395	Completed	Migraine	Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.\|Pfizer	2005-03	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eletriptan HBr selectively binds to and activates 5-HT1B and 5-HT1D serotonin receptors with Ki values of 0.92 nM and 3.14 nM, respectively, which inhibits adenylate cyclase activity and suppresses the release of pro-inflammatory neuropeptides from trigeminal nerve terminals. This receptor-mediated activation induces cranial blood vessel vasoconstriction and attenuates neurogenic inflammation, directly mediating its therapeutic efficacy in reducing acute migraine pain observed in clinical trials.

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>).