Smurf1-IN-A01 Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 470

Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 3 evaluations alongside unclassified studies investigate this compound for indications including contraception, advanced glioblastoma, nonalcoholic steatohepatitis, and attention-deficit/hyperactivity disorder. Sponsored by commercial entities such as Viatris Inc., Mylan Inc., and Janssen Pharmaceutical K.K., as well as academic institutions like the First Affiliated Hospital of Wannan Medical College and Tokyo Medical University, the trial portfolio reflects diverse recruitment statuses, including completed, actively recruiting, active non-recruiting, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06048536	Completed	Contraception	Viatris Inc.	2023-12-22	Phase 2
NCT06193538	Recruiting	Advanced Glioblastoma Patients	First Affiliated Hospital of Wannan Medical College	2023-09-14	Phase 1
NCT05139121	Active not recruiting	Contraception	Mylan Technologies Inc.\|Mylan Inc.\|Viatris Inc.	2021-10-26	Phase 3
NCT04012242	Unknown status	Nonalcoholic Steatohepatitis\|Ultrasound\|Elastography	Tokyo Medical University	2019-06-15	--
NCT01357993	Completed	Attention-Deficit / Hyperactivity Disorder	Janssen Pharmaceutical K.K.	2011-05	Phase 3

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

Check the Smurf1-IN-A01 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Smurf1-IN-A01 potently binds to the E3 ubiquitin ligase Smurf1 with a Kd of 3.664 nM, thereby blocking Smurf1-mediated degradation of Smad1/5 and accelerating BMP-2 signal responsiveness. By preventing proteasomal turnover of critical signaling effectors and enhancing BMP pathway activity, this agent alters cell fate decisions and cellular proliferation, offering mechanistic relevance to studied conditions such as advanced glioblastoma and nonalcoholic steatohepatitis.

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>).