Teduglutide — compound monograph
GLP-2 receptor agonist. Approved. The Institute assesses 1 outcome for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Teduglutide
- Compound class
- GLP-2 receptor agonist
- Assessment series
- Incretin receptor agonists
- Synonyms and codes
- ALX-0600 · teduglutide (INN) · Gattex (trade) · Revestive (trade)
- Route as evaluated
- Subcutaneous once daily
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- 197922-42-2
- Molecular formula
- C164H252N44O55S
- Average mass
- 3752.13
- Monoisotopic mass
- 3750.85
- ATC classification
- A16AX08
§1.3Sequence and structural notes
A 33-residue analogue of human glucagon-like peptide-2 in which alanine at position 2 is replaced by glycine. That single substitution confers resistance to dipeptidyl peptidase-4 and extends the half-life from minutes to hours. It is included in this series because it is the only approved GLP-2 receptor agonist and because it is frequently confused with GLP-1 agents in supply-side channels.
§1.4Assessment status
The Institute assesses Teduglutide across 1 indication and grades the strongest of them at moderate certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Teduglutide, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Inflammatory bowel disease and mucosal barrier disorders | Response defined as ≥20 % reduction in parenteral support volume in 63 % versus 30 % with placebo at 24 weeks | Moderate | 3 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.