Disitertide(P144) Clinical Trials

Size	Price	Qty
5mg	USD 357
25mg	USD 970

Clinical Trials

Disitertide (P144) has been investigated in several clinical trials to evaluate its therapeutic utility and safety profile. Initial clinical assessment included a Phase 1 trial (NCT00656825) sponsored by ISDIN, which focused on evaluating the tolerability and bioavailability of topical administration in healthy participants. The clinical development program subsequently advanced to Phase 2 studies, including trial NCT00574613 and its associated open-label extension study NCT00781053, to evaluate treatment efficacy and safety in patients presenting with skin fibrosis. All of these sponsored clinical trials have officially reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00781053	COMPLETED	Skin Fibrosis	ISDIN	2008-07	PHASE2
NCT00574613	COMPLETED	Skin Fibrosis	ISDIN	2007-09	PHASE2
NCT00656825	COMPLETED	Healthy	ISDIN	2007-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-02-11)

Check the Disitertide(P144) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Disitertide (P144) selectively binds to transforming growth factor-beta 1 (TGF-β1) to block its interaction with cell surface receptors, thereby inhibiting downstream profibrotic signaling pathways and modulating cellular responses. This targeted blockade suppresses aberrant extracellular matrix accumulation and pathological tissue remodeling, providing a therapeutic mechanism for managing skin fibrosis.

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>).