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Drug

Sitagliptin

Approved · EMA
Emerging researchLate-stage developmentCooling momentum
Also known as Brynovin, Janumet, Janumet XR, Januvia+7 more

Brynovin, Janumet, Janumet XR, Januvia, Juvisync, Steglujan, Zituvimet, Zituvio, Sitagliptina, Sitagliptine, Sitagliptinum.

19
Research papers
13
Active clinical trials
4
Regulatory events
Latest activity
beta

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

Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge.

Research2017-11-14American journal of physiology. Endocrinology and metabolism

Approval: Ristaben (EMA)

Regulatory2010-03-15EMA

Approval: Tesavel (EMA)

Regulatory2008-01-10EMA

Approval: Xelevia (EMA)

Regulatory2007-03-21EMA

Approval: Januvia (EMA)

Regulatory2007-03-20EMA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes
60%Moderate confidence
Uncertainty ±4%Evidence coverage: SubstantialUpdated 30 June 2026

Evidence is mixed35 supporting evidence families · 8 well-powered no-effect results

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Profile

Identifiers & mechanism

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

Canonical name
Sitagliptin
Aliases & brands
BrynovinJanumetJanumet XRJanuviaJuvisyncSteglujanZituvimetZituvioSitagliptinaSitagliptineSitagliptinum
RxNorm CUI
593411
ChEMBL ID
CHEMBL1422
UNII
QFP0P1DV7Z
Regulatory jurisdictions
ema

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-03-20
Latest approval
2010-03-15
Authorities
EMA
Total events
4
emaEuropean Medicines Agency· 4 events
2010-03-15Approval
Approval: Ristaben (EMA)
Indication: For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exerciseShow full indication

For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evidence ↗
2008-01-10Approval
Approval: Tesavel (EMA)
Indication: For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone andShow full indication

For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.

Evidence ↗
2007-03-21Approval
Approval: Xelevia (EMA)
Indication: For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exerciseShow full indication

For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

196 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
196
registered trials across all phases
LATEST COMPLETION 2026
13
Active studies
9
Recruiting
144
Late-stage (III+)
142
Completed
41
Discontinued
PHASE DISTRIBUTIONn = 196
Early Phase 11Phase 117Phase 1 / 24Phase 230Phase 2 / 35Phase 354Phase 465Phase N / A20

Late-stage studies

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

Recent completions

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

Research activity

19 papers

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

Publications over time
20102021
Most influential
Recent papers
Major research themes2
Diabetes Mellitus, Type 21Metformin1
Journals, researchers & institutions
Top journals
  • Diabetes, obesity & metabolism5
  • Diabetes care2
  • The Journal of clinical endocrinology and metabolism2
  • American heart journal1
  • American journal of kidney diseases : the official journal of the National Kidney Foundation1
  • American journal of physiology. Endocrinology and metabolism1
Leading researchers
  • Kaufman KD7
  • Engel SS4
  • Arjona Ferreira JC3
  • Bethel MA3
  • Goldstein BJ3
  • Green JB3
  • Holman RR3
  • Holst JJ3
Leading institutions
free-text, unnormalised
  • Garvan Institute of Medical Research2
  • Washington University School of Medicine2
  • Banting and Best Diabetes Centre1
  • Beijing Pinggu Hospital No. 591
  • Cambridge Institute of Medical Research and Department of Clinical Biochemistry1
  • Center for Human Nutrition1
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
  • Regulatory event sources are credited in the Regulatory Timeline above.