Pramlintide — compound monograph
Amylin analogue, short-acting. Approved. The Institute assesses 3 outcomes for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Pramlintide
- Compound class
- Amylin analogue, short-acting
- Assessment series
- Amylin analogues
- Synonyms and codes
- AC137 · tripro-amylin · pramlintide (INN) · Symlin (trade)
- Route as evaluated
- Subcutaneous immediately before major meals
§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
- 151126-32-8
- Molecular formula
- C171H267N51O53S2
- Average mass
- 3949.44
- Monoisotopic mass
- 3947.24
- ATC classification
- A10BX05
§1.3Sequence and structural notes
A 37-residue analogue of human amylin in which proline replaces alanine at position 25, serine at position 28 and serine at position 29. These three proline substitutions abolish the amyloidogenic self-assembly of native amylin while preserving receptor activity. An intramolecular disulfide bridge links Cys2 and Cys7.
§1.4Assessment status
The Institute assesses Pramlintide across 3 indications 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 Pramlintide, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Adjunctive therapy in type 1 diabetes | HbA1c reduction of approximately 0.3 % with weight reduction of 1.4 kg and reduced insulin requirement | Moderate | 1 |
| Type 2 diabetes mellitus | HbA1c −0.62 % versus −0.18 % with placebo at 52 weeks, with weight −1.4 kg | Moderate | 1 |
| Obesity and overweight in adults | −3.7 kg at 16 weeks versus placebo in a non-diabetic obesity study | Low | 1 |
| 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.