SAG (Smoothened Agonist) Hydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Multiple clinical trials currently investigate diverse conditions, including chronic hepatitis B infection, HIV/HBV coinfection, posterior cruciate ligament tears, and metabolic bone disorders. Spanning development stages such as Phase 1 clinical pharmacology studies, these trials encompass recruitment statuses including recruiting, active not recruiting, completed, and withdrawn. Sponsored by academic centers, health systems, and pharmaceutical companies such as Stanford University, the University of Melbourne, and Bayer, these studies evaluate optimized viral treatment protocols and cohort outcomes in infectious disease populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05937178	Recruiting	Hepatitis B Chronic	Huashan Hospital\|The First Affiliated Hospital of Anhui Medical University\|Anhui Provincial Hospital\|Beijing YouAn Hospital\|Peking University People''s Hospital\|Peking University First Hospital\|Xiamen Hospital of Traditional Chinese Medicine\|First Affiliated Hospital of Fujian Medical University\|LanZhou University\|Third Affiliated Hospital Sun Yat-Sen University\|First Affiliated Hospital of Guangxi Medical University\|The Affiliated Hospital Of Guizhou Medical University\|Hainan General Hospital\|Hebei Medical University Third Hospital\|The First Affiliated Hospital of Henan University of Traditional Chinese Medicine\|Henan Provincial People''s Hospital\|The Second Affiliated Hospital of Harbin Medical University\|Tongji Hospital\|Wuhan Union Hospital China\|Renmin Hospital of Wuhan University\|Central South University\|Xiangya Hospital of Central South University\|The First Hospital of Jilin University\|the Second Hospital of Nangjing\|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School\|The First Affiliated Hospital with Nanjing Medical University\|The Affiliated Hospital of Xuzhou Medical University\|The First Affiliated Hospital of Nanchang University\|Shengjing Hospital\|Qingdao Sixth People''s Hospital\|Shandong Provincial Hospital\|The Second Hospital of Shandong University\|The First Affiliated Hospital of Shanxi Medical University\|Tang-Du Hospital\|First Affiliated Hospital Xi''an Jiaotong University\|Ruijin Hospital\|West China Hospital\|Tianjin Second People''s Hospital\|First Affiliated Hospital of Xinjiang Medical University\|The First People''s Hospital of Yunnan\|Shulan (Hangzhou) Hospital\|Zhejiang University\|Southwest Hospital China\|The Second Affiliated Hospital of Chongqing Medical University\|Sichuan Provincial People''s Hospital	2023-01-31	--
NCT05701592	Recruiting	Posterior Cruciate Ligament Tear	Konrad Malinowski MD\|Artromedical Konrad Malinowski Clinic	2022-12-20	--
NCT06231056	COMPLETED	Genitourinary; Infection, Complicating Pregnancy	Liaquat University of Medical & Health Sciences	2019-01-01
NCT04165551	UNKNOWN	Streptococcus Agalactiae	Biosearch S.A.	2019-10-01	PHASE1
NCT03517943	COMPLETED	Clinical Pharmacology	Bayer	2018-04-24	PHASE1
NCT03517930	COMPLETED	Clinical Pharmacology	Bayer	2018-04-17	PHASE1
NCT03645044	Active not recruiting	Hiv\|HBV Coinfection	University of Melbourne\|National Health and Medical Research Council Australia\|The University of Western Australia\|University of Adelaide\|The HIV Netherlands Australia Thailand Research Collaboration\|University of Malaya\|YR Gaitonde Centre for AIDS Research and Education\|Melbourne Health	2018-05-24	--
NCT02718157	COMPLETED	Streptococcus Agalactiae Infection	Meridian Bioscience, Inc.	2016-08-10
NCT00990574	WITHDRAWN	Hypotension; Headache	Stanford University	2009-10
NCT01264094	TERMINATED	Chronic Hepatitis B	Bukwang Pharmaceutical	2009-11	PHASE4
NCT01820702	COMPLETED	Bone Diseases, Metabolic; Acid-Base Imbalance; Muscular Atrophy; Sprains and Strains; Protein Metabolism; Body Weight Changes; Cardiovascular Abnormalities	DLR German Aerospace Center	2010-11

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

Check the SAG (Smoothened Agonist) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SAG Hydrochloride acts as a potent Smoothened receptor agonist that binds Smoothened with an EC50 of 3 nM, triggering signal transduction through the Hedgehog pathway to induce transcription of target genes involved in cellular proliferation and cell fate determination. This activation of Hedgehog-mediated cellular differentiation and tissue remodeling provides a mechanistic foundation for therapeutic exploration in conditions studied in clinical trials, such as muscular atrophy and metabolic bone diseases.

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>).