Adavivint (SM04690) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 490

Clinical Trials

Multiple clinical trials, sponsored primarily by Biosplice Therapeutics, Inc., evaluate adavivint (SM04690) across Phase 1 to Phase 3 development for musculoskeletal disorders, including knee osteoarthritis, moderate to severe osteoarthritis, and degenerative disc disease. These studies assess safety, tolerability, pharmacokinetics, and endpoints related to bone health and joint structure. While several protocols have reached completion, select trials were terminated during evaluation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04385303	COMPLETED	Knee Osteoarthritis	Biosplice Therapeutics, Inc.	2020-05-26	PHASE3
NCT03928184	COMPLETED	Knee Osteoarthritis	Biosplice Therapeutics, Inc.	2019-05-17	PHASE3
NCT03727022	COMPLETED	Knee Osteoarthritis	Biosplice Therapeutics, Inc.	2018-11-28	PHASE2
NCT03706521	TERMINATED	Knee Osteoarthritis	Biosplice Therapeutics, Inc.	2019-03-11	PHASE2
NCT03246399	TERMINATED	Degenerative Disc Disease	Biosplice Therapeutics, Inc.	2017-07-26	PHASE1
NCT03727022	Completed	Knee Osteoarthritis	Biosplice Therapeutics Inc.	2018-11-28	Phase 2
NCT03122860	COMPLETED	Knee Osteoarthritis	Biosplice Therapeutics, Inc.	2017-04-24	PHASE2
NCT03246399	Terminated	Degenerative Disc Disease	Biosplice Therapeutics Inc.	2017-07-26	Phase 1
NCT02536833	COMPLETED	Osteoarthritis	Biosplice Therapeutics, Inc.	2015-09-09	PHASE2
NCT02095548	COMPLETED	Moderate to Severe Osteoarthritis	Biosplice Therapeutics, Inc.	2014-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-02-04)

Check the Adavivint (SM04690) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adavivint (SM04690) is a potent inhibitor of canonical Wnt signaling that inhibits TCF/LEF reporter activity with an EC50 of 19.5 nM, thereby suppressing downstream β-catenin-mediated gene transcription and cellular activation. By modulating Wnt-driven cellular differentiation and matrix turnover, this targeted inhibition promotes cartilage preservation and anti-inflammatory activity relevant to degenerative joint disorders such as osteoarthritis and degenerative disc disease.

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>).