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Drug

Linagliptin

Established medicine
ClassDipeptidyl peptidase IV inhibitorResearchOngoing clinical research
Also known as Glyxambi, Jentadueto, Tradjenta, Trijardy+2 more

Glyxambi, Jentadueto, Tradjenta, Trijardy, Linagliptina, (R)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione.

1
Research papers
2
Active clinical trials
Dipeptidyl peptidase 4
Primary target
41
Regulatory events
Latest activity
beta

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

Effect of Linagliptin on Vascular Function: A Randomized, Placebo-controlled Study.

Research2016-09-01The Journal of clinical endocrinology and metabolism

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
66%Moderate confidence
Uncertainty ±25%Evidence coverage: HighUpdated 11 August 2026

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.

Profile

Identifiers & mechanism

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

Canonical name
Linagliptin
Aliases & brands
GlyxambiJentaduetoTradjentaTrijardyLinagliptina(R)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione
RxNorm CUI
1100699
ChEMBL ID
CHEMBL237500
ATC codes
A10BH05
UNII
3X29ZEJ4R2
Primary mechanism
Dipeptidyl peptidase IV inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORDipeptidyl peptidase IV inhibitor

Regulatory timeline

41 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.

Approval / market entry confirmed across FDA and EMA (2011-08-232012-01-30)
Earliest approval
2011-08-23
Latest approval
2023-06-20
Authorities
FDA · EMA
Total events
41
fdaU.S. Food and Drug Administration· 40 events
2026-08-11Label change
Label change: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (NDA201281)
Evidence ↗
2026-08-11Label change
Label change: EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE (NDA212614)
Evidence ↗
2026-08-11Label change
Label change: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (NDA208026)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2011-08-23ApprovalMulti-authority
Approval: Trajenta (EMA)
Indication: Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exerciseShow full indication

Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Clinical trials

94 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
94
registered trials across all phases
LATEST COMPLETION 2026
2
Active studies
2
Recruiting
67
Late-stage (III+)
71
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 94
Phase 120Phase 1 / 22Phase 25Phase 331Phase 430Phase N / A6

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

1 papers

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

Most influential

Effect of Linagliptin on Vascular Function: A Randomized, Placebo-controlled Study.

The Journal of clinical endocrinology and metabolism · 2016 · 33 cites
Recent papers

Effect of Linagliptin on Vascular Function: A Randomized, Placebo-controlled Study.

The Journal of clinical endocrinology and metabolism · 2016 · 33 cites
Major research themes1
Outcome Assessment, Health Care1
Journals, researchers & institutions
Top journals
  • The Journal of clinical endocrinology and metabolism1
Leading researchers
  • Baltzis D1
  • Dushay JR1
  • Greenman RL1
  • Loader J1
  • Roustit M1
  • Veves A1
  • Wu J1
Leading institutions
free-text, unnormalised
  • Microcirculatory Laboratory and Rongxiang Xu1
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.