Drug

Sitagliptin Phosphate

In clinical development

ClassDipeptidyl peptidase IV inhibitorEmerging researchLate-stage developmentCooling momentum

Also known as Janumet, Janumet XR, Januvia, Juvisync+3 more

Janumet, Janumet XR, Januvia, Juvisync, Steglujan, Sitagliptin, sitagliptin (as phosphate).

RxNorm621590 ChEMBLCHEMBL1201174UNIITS63EW8X6F

Research papers

Dipeptidyl peptidase 4

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

DPP-4 inhibitors sitagliptin and PF-00734,200 mitigate dopaminergic neurodegeneration, neuroinflammation and behavioral impairment in the rat 6-OHDA model of Parkinson's disease.

Research2024-04-02GeroScience

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

Clinical trial2022-09-21Results posted · ClinicalTrials.gov

Exploring the Incretin Effect in People With IFG

Clinical trial2021-04-05Results posted · ClinicalTrials.gov

Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study.

Research2020-09-29Diabetes care

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess Efficacy, Safety and Tolerability of Sitagliptin Phosphate 100 mg as Treatment for Recurrent, Persistent or Newly Diagnosed Type 2 Diabetes After Gastric Bypass

Clinical trial2019-01-22Results posted · ClinicalTrials.gov

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Acarbose Monotherapy

Clinical trial2018-08-16Results posted · ClinicalTrials.gov

A Phase III, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Clinical trial2017-06-05Results posted · ClinicalTrials.gov

A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin

Clinical trial2017-06-05Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin

Clinical trial2017-05-30Results posted · ClinicalTrials.gov

An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Clinical trial2017-05-30Results posted · ClinicalTrials.gov

Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Research2011-03-23Current medical research and opinion

Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial.

Research2010-07-01Diabetes, obesity & metabolism

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sitagliptin Phosphate

Aliases & brands

JanumetJanumet XRJanuviaJuvisyncSteglujanSitagliptinsitagliptin (as phosphate)

RxNorm CUI

621590

ChEMBL ID

CHEMBL1201174

UNII

TS63EW8X6F

Primary mechanism

Dipeptidyl peptidase IV inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Dipeptidyl peptidase 4

DPP4 · P27487

INHIBITORDipeptidyl peptidase IV inhibitor

Clinical trials

32 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2016

Late-stage (III+)

Completed

PHASE DISTRIBUTIONn = 32

Phase 17Phase 22Phase 317Phase 44Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial

CompletedPH IVInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirann=202011

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

CompletedPH IVKey trialMerck Sharp & Dohme LLCn=1,1472010

A 24 Week, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Adding Sitagliptin 100 mg Once Daily in Patients With T2DM Who Have Inadequate Glycemic Control on Metformin Therapy

CompletedPH IVMerck Sharp & Dohme LLCn=6082009

Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise

CompletedPH IVMerck Sharp & Dohme LLCn=292008

CompletedPH IIIMerck Sharp & Dohme LLCn=3802013

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedN/ABlandine Laferreren=372016

CompletedPH IIIMerck Sharp & Dohme LLCn=3802013

CompletedPH IIIMerck Sharp & Dohme LLCn=4802012

CompletedPH IIIMerck Sharp & Dohme LLCn=4272012

A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

CompletedPH IIIKey trialMerck Sharp & Dohme LLCn=1,6152011

Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial

CompletedPH IVInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirann=202011

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20072024

Most influential

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin.

Diabetes, obesity & metabolism · 2007 · 352 cites

Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes.

Diabetes, obesity & metabolism · 2010 · 224 cites

Diabetes care · 2020 · 185 cites

Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes.

Diabetes, obesity & metabolism · 2010 · 123 cites

Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Current medical research and opinion · 2011 · 107 cites

Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.

Endocrine journal · 2010 · 84 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Diabetes Mellitus, Type 22

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Metformin

Studied across 3 of the same disease areas as Sitagliptin Phosphate in the shared literature.

3 shared diseases1 shared paper

Glimepiride

Studied across 2 of the same disease areas as Sitagliptin Phosphate in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials