Product Description
Regeneron is developing REGN-4461 as a treatment for Generalized Lipodystrophy. (Sourced from: https://classic.clinicaltrials.gov/ct2/show/NCT04159415)
Mechanisms of Action: Leptin Agonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous, Subcutaneous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Regeneron
Company Location: Eastern America
Company Founding Year: 1988
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: France, Germany, United States
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Hypertriglyceridemia|Insulin Resistance|Lipodystrophy|Lipodystrophy, Congenital Generalized|Lipodystrophy, Familial Partial|Obesity|Obesity, Morbid
Phase 2: Anovulation
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07235917 |
KYRIAD | P2 |
Recruiting |
Anovulation |
2027-08-20 |
23% |
2026-03-27 |
|
2024-519879-25-00 |
R4461-GLD-2285 | P3 |
Not yet recruiting |
Lipodystrophy |
2029-06-05 |
35% |
||
2024-518674-14-00 |
R4461-MOB-2471 | P3 |
Not yet recruiting |
Obesity |
2028-01-14 |
22% |
||
NCT06548100 |
R4461-GLD-2284 | P3 |
Completed |
Lipodystrophy, Congenital Generalized|Hypertriglyceridemia|Obesity, Morbid|Insulin Resistance|Lipodystrophy, Familial Partial |
2026-07-09 |
11% |
2026-07-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT07220785 |
LAGO | P3 |
Recruiting |
Lipodystrophy, Congenital Generalized|Lipodystrophy, Familial Partial |
2028-05-19 |
35% |
2026-07-14 |
Primary Endpoints|Treatments |
NCT06373146 |
I8F-MC-GPIV | P2 |
Completed |
Obesity |
2025-12-15 |
50% |
2026-05-07 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2021-000138-33 |
2021-000138-33 | P2 |
Active, not recruiting |
Lipodystrophy, Familial Partial |
2024-01-26 |
2022-03-13 |
Treatments |
|
NCT07220772 |
R4461-MOB-2471 | P3 |
Recruiting |
Obesity, Morbid |
2027-06-18 |
22% |
2026-03-11 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/11/2023 |
News Article |
Lipodystrophy Market To Experience Major Change By 2032, Predicts Delveinsight |
|
01/07/2019 |
News Article |
Regeneron Provides Update on Commercial and Pipeline Progress at J.P. Morgan Healthcare Conference |