Teduglutide

Summary

Teduglutide (CHEMBL2104987) is an approved protein glucagon-like peptide-2 receptor agonist (ATC A16AX08) targeting GLP2R; indicated across 10 conditions including short bowel syndrome and malabsorption syndrome.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: A16AX08
• Targets: 1 (GLP2R)
• Indications: 10 conditions
• Clinical trials: 41
• Chemistry: 3752.1 Da · C164H252N44O55S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2104987
Name	Teduglutide
Type	Protein
Max phase	4
FDA approved	no
PubChem CID	70683012
ChEBI	CHEBI:72305
ATC	A16AX08
Molecular formula	C164H252N44O55S
Molecular weight	3752.1
InChIKey	CILIXQOJUNDIDU-ASQIGDHWSA-N

SMILES: CC[C@H](C)[C@@H](C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)O)C(=O)O)NC(=O)[C@H](CCCCN)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CNC2=CC=CC=C21)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC4=CC=CC=C4)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC5=CNC=N5)N

IUPAC name: (2S)-2-[[(2S,3R)-2-[[(2S,3S)-2-[[(2S)-6-amino-2-[[(2S,3R)-2-[[(2S)-5-amino-2-[[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3S)-2-[[(2S,3R)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[2-[[(2S)-2-amino-3-(1H-imidazol-4-yl)propanoyl]amino]acetyl]amino]-3-carboxypropanoyl]amino]acetyl]amino]-3-hydroxypropanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-4-carboxybutanoyl]amino]-4-methylsulfanylbutanoyl]amino]-4-oxobutanoyl]amino]-3-hydroxybutanoyl]amino]-3-methylpentanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-4-oxobutanoyl]amino]-4-methylpentanoyl]amino]propanoyl]amino]propanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-carboxypropanoyl]amino]-3-phenylpropanoyl]amino]-3-methylpentanoyl]amino]-4-oxobutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-methylpentanoyl]amino]-5-oxopentanoyl]amino]-3-hydroxybutanoyl]amino]hexanoyl]amino]-3-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]butanedioic acid

ChEBI definition: A 33-membered polypeptide consisting of His, Gly, Asp, Gly, Ser, Phe, Ser, Asp, Glu, Met, Asn, Thr, Ile, Leu, Asp, Asn, Leu, Ala, Ala, Arg, Asp, Phe, Ile, Asn, Trp, Leu, Ile, Gln, Thr, Lys, Ile, Thr and Asp residues joined in sequence. A glucagon-like peptide-2 receptor agonist used for the treatment of short-bowel syndrome.

Pharmacological roles (ChEBI): glucagon-like peptide-2 receptor agonist, antioxidant, protective agent.

Other ChEBI roles (chemical / environmental): metabolite.

Also known as: ALX 0600, ALX-0600, Gattex, Gattex kit, Revestive, Teduglutida, Teduglutide, Teduglutide (rdna origin), Teduglutide recombinant, TEDUGLUTIDE

Patent coverage: 545 distinct patent families (1,308 SureChEMBL compound mentions), from 4 matched compound structure(s). One matched structure accounts for 960 (73%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
GLP2R	GLP-2 receptor	Agonist	10.7	0%	O95838

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Glucagon-like peptide 2 receptor, Glucagon-like peptide 2 receptor.

Bioactivity

ChEMBL activities: 4 potent at pChembl ≥ 5 of 4 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
GLP2R	11	EC50	0.01	nM	CHEMBL_ACT_18718381
GLP2R	10.52	EC50	0.03	nM	CHEMBL_ACT_29150983
Q9Z0W0	10.1	EC50	0.08	nM	CHEMBL_ACT_16634849
GLP2R	10.05	EC50	0.09	nM	CHEMBL_ACT_16633285

Target pathways

Aggregated over 1 target gene(s): GLP2R.

Top Reactome pathways

2 total, by targets touching each:

Pathway	Targets	Genes
G alpha (s) signalling events	1	GLP2R
Glucagon-type ligand receptors	1	GLP2R

Dominant GO biological processes

GO term	Targets
cell surface receptor signaling pathway	1
adenylate cyclase-modulating G protein-coupled receptor signaling pathway	1
positive regulation of cell population proliferation	1
signal transduction	1
G protein-coupled receptor signaling pathway	1
cellular response to glucagon stimulus	1

Indications & clinical

Indications

10 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
short bowel syndrome	4	MONDO:0015183	MONDO:0015183
malabsorption syndrome	4	MONDO:0020598	EFO:0009554
Crohn disease	2	MONDO:0005011	EFO:0000384
HIV infectious disease	2	MONDO:0005109	EFO:0000764
hyperlipidemia	2	MONDO:0021187	MONDO:0021187
liver disorder	1	MONDO:0005154	EFO:0001421
kidney disorder	1	MONDO:0005240	EFO:0003086
graft versus host disease	0	MONDO:0013730	MONDO:0013730

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 41.

Phase distribution

Phase	Trials
PHASE3	17
PHASE2	6
PHASE1	6
Not specified	6
PHASE2/PHASE3	3
PHASE4	2
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02099084	PHASE4	COMPLETED	Short Bowel Syndrome and Teduglutide Versus Placebo
NCT03562130	PHASE4	COMPLETED	Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
NCT06973304	PHASE3	RECRUITING	A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
NCT00081458	PHASE3	COMPLETED	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
NCT00172185	PHASE3	COMPLETED	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
NCT00798967	PHASE3	COMPLETED	Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
NCT00930644	PHASE3	COMPLETED	Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
NCT01560403	PHASE3	COMPLETED	A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
NCT01952080	PHASE3	COMPLETED	A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
NCT02340819	PHASE3	COMPLETED	Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
NCT02682381	PHASE3	COMPLETED	Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
NCT02949362	PHASE3	COMPLETED	Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
NCT02980666	PHASE3	COMPLETED	Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
NCT03268811	PHASE3	COMPLETED	A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
NCT03422666	PHASE2/PHASE3	COMPLETED	Plasma Lipoprotein Response to Glucagon-like Peptide-2
NCT03442972	PHASE2/PHASE3	COMPLETED	Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids
NCT03534661	PHASE2/PHASE3	COMPLETED	L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release
NCT03571516	PHASE3	COMPLETED	Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
NCT03596164	PHASE3	COMPLETED	An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
NCT03663582	PHASE3	COMPLETED	Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
NCT03953170	PHASE3	WITHDRAWN	Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
NCT05027308	PHASE3	COMPLETED	A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
NCT07537686	PHASE2	NOT_YET_RECRUITING	Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
NCT00072839	PHASE2	COMPLETED	Safety and Efficacy of ALX-0600 in Subjects With Active Crohn’s Disease
NCT00308438	PHASE2	COMPLETED	Safety and Efficacy of ALX-0600 in Subjects With Active Crohn’s Disease Who Completed Protocol CL0600-008
NCT02431325	PHASE2	COMPLETED	A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
NCT02889393	PHASE2	COMPLETED	Teduglutide for Enterocutaneous Fistula (ECF)
NCT03716115	PHASE2	COMPLETED	Therapeutic Approaches to Malnutrition Enteropathy
NCT00819468	PHASE1	COMPLETED	Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
NCT00820885	PHASE1	COMPLETED	A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
NCT01028768	PHASE1	COMPLETED	Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
NCT01028924	PHASE1	COMPLETED	Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
NCT01209351	PHASE1	COMPLETED	Effect of Teduglutide on Gastric Emptying in Healthy Subjects
NCT04465396	PHASE1	COMPLETED	A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
NCT04290429	EARLY_PHASE1	COMPLETED	Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients
NCT05023382	Not specified	ACTIVE_NOT_RECRUITING	A Study of Teduglutide in Japanese People With Short Bowel Syndrome
NCT07400783	Not specified	RECRUITING	TED_ORG: Study on Short Bowel Syndrome
NCT04733066	Not specified	UNKNOWN	Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
NCT04832087	Not specified	COMPLETED	Pediatric Teduglutide Registry
NCT04857801	Not specified	COMPLETED	Teduglutide in Short Bowel Syndrome Patients

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).