Wednesday, July 8, 2026

Drug profile · INN

saxagliptin hydrochloride

saxagliptin hydrochloride (SAXAGLIPTIN) is a dipeptidyl peptidase iv inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 3
News articles 0
Drug details — saxagliptin hydrochloride
US status
approved
Class
Route
ORAL
Patents
1
Programs
3
Data quality
0.89

Quick answer

saxagliptin hydrochloride (SAXAGLIPTIN) is a dipeptidyl peptidase iv inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN saxagliptin hydrochloride
Brand SAXAGLIPTIN
Mechanism Dipeptidyl peptidase IV inhibitor
Target Dipeptidyl peptidase 4
Route ORAL
Formulation TABLET

Mechanism of action

Dipeptidyl peptidase IV inhibitor

Primary target: Dipeptidyl peptidase 4

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. ANDA219975 + ANDA220011 Phase 3 · Lxo Ireland Designated · Type 2 Diabetes
  2. Saxagliptin Phase 3 · AstraZeneca · Diabetes
  3. saxagliptin Phase 2 · Kyowa Kirin International · Diabetes, Type 2

Related & competitor drugs

  1. alogliptin benzoate Alimentary tract and metabolism (A10)
  2. linagliptin Alimentary tract and metabolism (A10)
  3. sitagliptin phosphate Dipeptidyl peptidase IV inhibitor
  4. begelomab Antineoplastic and immunomodulating agents (L04)
  5. sitagliptin fumarate Alimentary tract and metabolism (A10)
  6. sitagliptin hydrochloride monohydrate Alimentary tract and metabolism (A10)
  1. US 8410288

    Polymorphs of Saxagliptin hydrochloride and processes for preparing them

    Expires Mon Mar 28 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is saxagliptin hydrochloride?

saxagliptin hydrochloride (SAXAGLIPTIN) is a dipeptidyl peptidase iv inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for saxagliptin hydrochloride?

SAXAGLIPTIN is a marketed brand name for saxagliptin hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of saxagliptin hydrochloride?

saxagliptin hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.