Teduglutide (ALX-0600) Clinical Trials

Size	Price	Qty
5mg	USD 277
25mg	USD 837

Clinical Trials

Numerous clinical trials, ranging from Early Phase 1 through Phase 4, investigate teduglutide for conditions including short bowel syndrome, intestinal failure, hyperlipidemias, Crohn's disease, severe acute malnutrition, and environmental enteric dysfunction. Encompassing active, completed, and withdrawn protocols, these studies evaluate outcomes such as clinical effectiveness and metabolic responses to demonstrate the drug's therapeutic scope. Research sponsorship is shared between pharmaceutical entities like Takeda and major academic institutions, including Universitaire Ziekenhuizen KU Leuven, Assistance Publique - Hôpitaux de Paris, and the Medical University of Vienna.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07537686	NOT_YET_RECRUITING	Environmental Enteric Dysfunction	International Centre for Diarrhoeal Disease Research, Bangladesh	2026-07-01	PHASE2
NCT06973304	RECRUITING	Short Bowel Syndrome	Takeda	2025-06-26	PHASE3
NCT07400783	RECRUITING	Short Bowel Syndrome (SBS)	Meyer Children's Hospital IRCCS	2024-10-30
NCT05027308	COMPLETED	Short Bowel Syndrome	Takeda	2022-01-04	PHASE3
NCT03953170	WITHDRAWN	Ileostomy - Stoma	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	2022-06-02	PHASE3
NCT03596164	COMPLETED	Short Bowel Syndrome	Takeda	2018-07-09	PHASE3
NCT04883606	Completed	Short Bowel Syndrome	Takeda	2022-01-26	--
NCT03268811	COMPLETED	Short Bowel Syndrome	Shire	2017-08-23	PHASE3
NCT04465396	COMPLETED	Healthy Volunteers	Shire	2021-01-13	PHASE1
NCT03422666	COMPLETED	Hyperlipidemias	University Health Network, Toronto	2018-09-21	PHASE2; PHASE3
NCT03442972	COMPLETED	Hyperlipidemias	University Health Network, Toronto	2019-01-17	PHASE2; PHASE3
NCT03716115	COMPLETED	Severe Acute Malnutrition	Queen Mary University of London	2020-05-04	PHASE2
NCT04344717	Recruiting	Short Bowel Syndrome\|Anticoagulation	Universitaire Ziekenhuizen KU Leuven	2020-12-20	Phase 4
NCT02954458	COMPLETED	Short Bowel Syndrome	Shire	2017-01-09	PHASE3
NCT03571516	COMPLETED	Short Bowel Syndrome	Shire	2018-08-31	PHASE3
NCT04733066	Unknown status	Short Bowel Syndrome\|Intestinal Failure	Charite University Berlin Germany\|Takeda	2020-09-01	--
NCT02889393	COMPLETED	Postoperative Fistula	Daniel Dante Yeh	2019-01-31	PHASE2
NCT02949362	COMPLETED	Short Bowel Syndrome	Shire	2016-12-09	PHASE3
NCT02980666	COMPLETED	Short Bowel Syndrome	Shire	2017-01-13	PHASE3
NCT02431325	COMPLETED	HIV	Massachusetts General Hospital	2015-12	PHASE2
NCT03562130	COMPLETED	Short Bowel Syndrome	Assistance Publique - Hôpitaux de Paris	2018-07-02	PHASE4
NCT04290429	COMPLETED	Graft Versus Host Disease	University of Freiburg	2017-12-06	EARLY_PHASE1
NCT03663582	COMPLETED	Short Bowel Syndrome	Shire	2018-07-06	PHASE3
NCT03860688	Unknown status	Hyperlipidemias	University Health Network Toronto	2019-05-01	Phase 2\|Phase 3
NCT03534661	COMPLETED	Hyperlipidemias	University Health Network, Toronto	2017-09-27	PHASE2; PHASE3
NCT03442972	Completed	Hyperlipidemias	University Health Network Toronto\|Kensington Screening Clinic	2019-01-17	Phase 2\|Phase 3
NCT02340819	COMPLETED	Short Bowel Syndrome	Shire	2014-12-18	PHASE3
NCT02682381	COMPLETED	Short Bowel Syndrome	Shire	2016-06-23	PHASE3
NCT02099084	COMPLETED	Short Bowel Syndrome	Mayo Clinic	2014-01	PHASE4
NCT01952080	COMPLETED	Short Bowel Syndrome	Shire	2013-11-14	PHASE3
NCT01560403	COMPLETED	Short Bowel Syndrome	Shire	2012-05-21	PHASE3
NCT00930644	COMPLETED	Short Bowel Syndrome	Shire	2009-09-21	PHASE3
NCT00798967	COMPLETED	Short Bowel Syndrome	Shire	2008-11-25	PHASE3
NCT01209351	COMPLETED	Healthy Volunteers	Shire	2010-09-28	PHASE1
NCT01028924	COMPLETED	Healthy	Nycomed	2009-11	PHASE1
NCT01028768	COMPLETED	Renal Impairment	Nycomed	2009-10	PHASE1
NCT00172185	COMPLETED	Short Bowel Syndrome	Shire	2005-01-10	PHASE3
NCT00819468	COMPLETED	Hepatic Impairment	Shire	2007-07-26	PHASE1
NCT00081458	COMPLETED	Short Bowel Syndrome	Shire	2004-05-25	PHASE3
NCT00820885	COMPLETED	Pharmacokinetics and Safety of Elevated Doses	Shire	2006-09-06	PHASE1
NCT00308438	COMPLETED	Crohn's Disease	Shire	2004-03-01	PHASE2
NCT00072839	COMPLETED	Crohn's Disease	Shire	2003-11-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-17)

Check the Teduglutide (ALX-0600) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Teduglutide is an analogue of human glucagon-like peptide-2 that selectively binds to GLP-2 receptors to activate downstream trophic signaling pathways, promoting mucosal proliferation and structural intestinal repair. By increasing villus height and crypt cell depth to maximize nutrient absorption, this mucosal expansion directly counteracts malabsorption and intestinal insufficiency in conditions such as short bowel syndrome.

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>).