Pipeline › lixisenatide
lixisenatide
FDA-approved since 2016 and marketed in the US as Adlyxin, Soliqua, authorised in the EU as Lyxumia, Suliqua, with no open FDA shortage or discontinuation records. 4 active trials, the next due to complete 2027-06-30.
incretin (auto-detected) agonist, unknown, from Sanofi. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- phase3
- Target
- incretin (auto-detected)
- Route
- unknown
- Sponsor
- Sanofi
- First FDA approval
- 2016-07-27
- EU authorisation
- Suliqua (2017), Lyxumia (2017)
- Active trials
- 4 (0 in phase 3)
- Participants enrolled
- 2,418
- Trials with a reporting date
- 3
- Approved FDA submissions
- 19
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use ( 1 ) : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin. Limitations of Use : SOLIQUA 100/33 contains lixisenatide. Coadministration with any other product containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions (5.5) ] . SOLIQUA 100/33 is not recommended for the treatment of diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in combination with prandial insulin.
Recent changes
When these trials report
Next 3 of 3 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2027-06-30 | Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents NCT07307235 · hemoglobin A1c (HbA1c) change | Shanghai Zhongshan Hospital | P4 | 1,316 |
| 2027-06-30 | Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes NCT07173712 · Proportion of subjects with optimal glycemic control | Yanbing Li | P4 | 324 |
| 2028-02-09 | Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes NCT07117240 · Glucose monitoring index and Time in range | Medical University of Warsaw | P4 | 100 |
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-03-12 | Labeling | ADLYXIN | BLA208471 · label |
| 2026-03-12 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2025-05-28 | Labeling | ADLYXIN | BLA208471 · label |
| 2025-05-28 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2024-11-01 | Labeling | ADLYXIN | BLA208471 · label |
| 2024-11-01 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2023-09-28 | Labeling | ADLYXIN | BLA208471 · label |
| 2023-09-28 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2022-06-10 | Labeling | ADLYXIN | BLA208471 · label |
| 2022-06-10 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2021-07-30 | Efficacy | ADLYXIN | BLA208471 · label |
| 2021-07-28 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2019-11-15 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2019-11-15 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2019-02-27 | Efficacy | SOLIQUA 100/33 | BLA208673 · label |
| 2017-09-28 | Manufacturing (CMC) | SOLIQUA 100/33 | BLA208673 |
| 2017-08-29 | Labeling | SOLIQUA 100/33 | BLA208673 · label |
| 2016-11-21 | Type 4 - New Combination original | SOLIQUA 100/33 | BLA208673 · label |
| 2016-07-27 | Type 1 - New Molecular Entity original | ADLYXIN | BLA208471 · label |
Indications under study
Diabetes; Steroid-Induced Diabetes; Steroid-Induced Hyperglycemia; Type 2 Diabetes; Type 2 Diabetes (T2D).
Recent papers
Every lixisenatide trial on file
All 51 registered trials of lixisenatide, largest first. Each links to its own page and to the registry record.