Product Description
Lixisenatide is a 44-amino acid peptide. Like exenatide, it is based on exendin-4 with a modification at the C-terminus—a deletion of a proline residue and the addition of six lysine residues.15 It is amidated at the C-terminal amino acid (position 44) (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5642155/)
Mechanisms of Action: GLP-1 Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Type 2 Diabetes|Diabetic Nephropathy|Hypoglycemia|Kidney Diseases|Pituitary Diseases|Type 1 Diabetes
Phase 3: Type 2 Diabetes|Acute Coronary Syndrome|Angina, Stable|General Diabetes
Phase 2: Type 2 Diabetes|Gastroparesis|General Diabetes|Hyperlipidemia|Parkinson's Disease|Type 1 Diabetes
Phase 1: Type 1 Diabetes|Type 2 Diabetes
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05220917 |
CER-4-T2D | N/A |
Active, not recruiting |
Type 2 Diabetes|Kidney Diseases |
2026-01-31 |
2025-12-11 |
||
NCT02244164 |
Incretine study | N/A |
Terminated |
Type 2 Diabetes |
2023-02-13 |
2023-02-18 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
ChiCTR2000037907 |
ChiCTR2000037907 | N/A |
Not yet recruiting |
Type 2 Diabetes |
2022-12-31 |
|||
ChiCTR2100041657 |
ChiCTR2100041657 | N/A |
Recruiting |
Body Weight Changes|Hypoglycemia|Type 2 Diabetes |
2022-03-31 |
|||
ACTRN12620000200987p |
M10-855 | N/A |
Not yet recruiting |
Type 1 Diabetes |
2020-08-03 |
|||
ACTRN12619000897167p |
2006-7041-83/hah | N/A |
Not yet recruiting |
Environmental Hypersensitivity|Food Hypersensitivity |
2019-12-20 |
|||
NCT02803918 |
TDR14311 | P1 |
Completed |
Type 2 Diabetes |
2020-01-27 |
50% |
2020-01-31 |
Primary Endpoints|Treatments|Trial Status |
2015-005789-42 |
2015-005789-42 | P1 |
Completed |
Type 2 Diabetes |
2020-01-27 |
2022-03-13 |
Treatments |
|
NCT03439943 |
LixiPark | P2 |
Completed |
Parkinson's Disease |
2021-04-15 |
78% |
2023-06-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03798054 |
Lixilan-O-AP | P3 |
Completed |
Type 2 Diabetes |
2021-03-01 |
53% |
2021-03-06 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
CTR20181388 |
CTR20181388 | P3 |
Completed |
Type 2 Diabetes |
2021-03-01 |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT03767543 |
LixilanOne CAN | P3 |
Completed |
Type 2 Diabetes |
2020-10-23 |
30% |
2020-11-04 |
|
2017-003370-13 |
Global Premix | P3 |
Completed |
Type 2 Diabetes |
2020-07-20 |
2022-03-13 |
Treatments |
|
NCT03529123 |
LixiLan-India | P3 |
Completed |
Type 2 Diabetes |
2019-11-25 |
45% |
2020-11-13 |
|
NCT06671587 |
China Soli-CGM | P4 |
Recruiting |
Type 2 Diabetes |
2026-09-18 |
2024-12-13 |
Primary Endpoints |
|
NCT06716424 |
LPS18016 | P4 |
Recruiting |
Type 2 Diabetes |
2026-04-03 |
2025-07-17 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT05804513 |
Lixi22 | P4 |
Unknown status |
Pituitary Diseases|Type 1 Diabetes |
2023-10-31 |
2025-06-03 |
||
2021-003711-25 |
SoliSwitch LPS17008 | P4 |
Completed |
Type 2 Diabetes |
2023-07-21 |
|||
NCT05114590 |
Soli-CGM | P4 |
Completed |
Type 2 Diabetes |
2023-03-28 |
2024-05-25 |
Patient Enrollment|Primary Endpoints|Treatments |
|
2019-002977-69 |
BEYOND | P4 |
Completed |
Type 2 Diabetes |
2021-11-14 |
2025-05-06 |
Treatments|Trial Status |
|
2019-004080-43 |
SUPERB-CGM | P4 |
Active, not recruiting |
Type 2 Diabetes |
2021-02-20 |
2022-03-13 |
Treatments |
|
2018-003557-21 |
2018-003557-21 | P4 |
Terminated |
Type 2 Diabetes |
2020-06-29 |
2022-03-13 |
Treatments |
|
NCT03819790 |
VARIATION 2 SA | P4 |
Completed |
Type 2 Diabetes |
2019-11-19 |
2021-02-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
2016-001758-17 |
LAST | P4 |
Unknown status |
Type 2 Diabetes |
2019-11-14 |
2022-03-13 |
Treatments |
|
2014-002178-35 |
ELIXIRS: Effect of LIXIsenatide on the Renal System | P4 |
Completed |
Type 2 Diabetes |
2019-08-14 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/24/2025 |
News Article |
U.S. Diabetes Market Set to Surge 60% by 2031 Amid GLP-1 Innovations and CGM Expansion |
|
02/18/2025 |
News Article |
Injectable Drug Delivery Devices Market Size Expected to Reach USD 1,217 Bn by 2034 |
|
07/24/2024 |
News Article |
GLP-1 Market Size to Reach USD 95.4 Billion with a CAGR of 10.3% from 2024 to 2031 - Says InsightAce Analytic |
|
07/04/2024 |
News Article |
Peptide Therapeutics Market size is set to grow by USD 17.85 billion from 2024-2028, Increasing prevalence of infectious diseases to boost the market growth, Technavio |