Terevalefim Clinical Trials

Size	Price	Qty
5mg	USD 159

Clinical Trials

Multiple clinical trials evaluate the small-molecule HGF mimetic Terevalefim (ANG-3777) in Phase 1 investigations with an unknown recruitment status. Sponsored by Angion Biomedica Corp in collaboration with Nucleus Network Ltd and Quotient Sciences, these studies assess safety, pharmacokinetics, mass balance recovery, metabolism, and excretion of the compound. Together, they establish the drug's safety parameters and pharmacokinetic profile in both healthy male volunteers and stable adult patients undergoing maintenance hemodialysis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04958187	Unknown status	Hemodialysis	Angion Biomedica Corp\|Nucleus Network Ltd	2021-07	Phase 1
NCT04931524	Unknown status	Healthy	Angion Biomedica Corp\|Quotient Sciences	2021-05-21	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a small-molecule hepatocyte growth factor (HGF) mimetic, Terevalefim selectively induces c-MET receptor dimerization and phosphorylation, thereby triggering downstream signaling pathways that reduce cellular apoptosis and promote cell proliferation. This regenerative and pro-survival cellular activity supports renal tissue protection, providing the physiological rationale for clinical investigations evaluating the compound in healthy subjects and patients undergoing hemodialysis.

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>).