Telotristat Etiprate (LX 1606 Hippurate) Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple clinical trials have evaluated the pharmacokinetic profile and clinical safety of Telotristat Etiprate in completed Phase I studies sponsored by Ipsen and Lexicon Pharmaceuticals. These investigations assessed drug disposition in special populations, specifically individuals with renal or hepatic impairment, alongside potential drug interactions with concomitant treatment regimens. Collectively, these completed trials provide critical safety and dosing parameters to guide clinical management across varied physiological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03442725	Completed	Renal Impairment	Ipsen	2018-02-09	Phase 1
NCT03423446	Completed	Hepatic Impairment	Lexicon Pharmaceuticals	2017-11-28	Phase 1
NCT02683577	Completed	Hepatic Impairment	Ipsen	2016-02	Phase 1
NCT02195635	Completed	Drug Interactions	Lexicon Pharmaceuticals	2014-07	Phase 1

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

Check the Telotristat Etiprate (LX 1606 Hippurate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Upon metabolic conversion to LP-778902, Telotristat Etiprate selectively binds to and inhibits tryptophan hydroxylase, the rate-limiting enzyme in serotonin biosynthesis. This enzymatic inhibition blocks peripheral serotonin production, reducing serotonin-mediated signaling to mitigate severe gastrointestinal diarrhea in clinical conditions evaluated across renal, hepatic, and drug interaction studies.

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>).