lerodalcibep
Trade name: Lerochol
Recombinant proteinapproved
Approved
Dec 12, 2025
Clinical trial activity
14 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
12
Phase 3
10
Phase 4
0
Earliest trial started Oct 30, 2017 (NCT03545438)
Timeline
2010s
- Jan 1, 2017
LIB Therapeutics LLC — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2018
LIB Therapeutics LLC — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2019
LIB Therapeutics LLC — Earliest Phase 3 Sponsor(trial)
2020s
- Dec 12, 2025
Earliest FDA Approval
- Dec 12, 2025
LIB Therapeutics LLC — Marketing Organization
Indications
Approved for
Studied for
- Atherosclerosis · Phase 3
- Cardiovascular Diseases · Phase 3
- Cholesterol, LDL · Phase 2
- Dyslipidemias · Phase 3
- Healthy Volunteers · Phase 1
- Heart Disease Risk Factors · Phase 3
- Heart Diseases · Phase 3
- Homozygous Familial Hypercholesterolemia · Phase 3
- Hyperlipidemias · Phase 3
- Hyperlipoproteinemia Type II · Phase 3
- Lipid Metabolism Disorders · Phase 1
- Metabolic Diseases · Phase 3
- Myocardial Infarction · Phase 3
- Sclerosis · Phase 3
Mechanism of action
- Subtilisin/kexin type 9INHIBITOR
Subtilisin/kexin type 9 inhibitor
Approval history
- approvedDec 12, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4650405 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07102511 | Phase 3 | Sep 1, 2025 | LIB Therapeutics LLC |
| NCT06568471 | Phase 3 | Sep 30, 2024 | Hasten Biopharmaceutical Co., Ltd., Peking University |
| NCT06504043 | Phase 1 | Aug 31, 2024 | Hasten Biopharmaceutical Co., Ltd., Medpace, Inc. |
| NCT05234775 | Phase 3 | Jan 28, 2022 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT05004675 | Phase 3 | Oct 15, 2021 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT04806893 | Phase 3 | Apr 22, 2021 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT04790513 | Phase 3 | Apr 22, 2021 | LIB Therapeutics LLC |
| NCT04797104 | Phase 3 | Apr 22, 2021 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT04797247 | Phase 3 | Apr 22, 2021 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT04798430 | Phase 3 | Dec 3, 2020 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT04034485 | Phase 3 | Aug 12, 2019 | LIB Therapeutics LLC |
| NCT03847974 | Phase 2 | Feb 14, 2019 | LIB Therapeutics LLC |
| NCT03549260 | Phase 2 | May 22, 2018 | LIB Therapeutics LLC, Medpace, Inc. |
| NCT03545438 | Phase 1 | Oct 30, 2017 | LIB Therapeutics LLC, Medpace, Inc. |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| LIB Therapeutics LLC | For profit | 12 | 12 | 3 | 2017 |
| Medpace, Inc. | For profit | 9 | 0 | 3 | 2017 |
| Hasten Biopharmaceutical Co., Ltd. | For profit | 2 | 2 | 2 | 2024 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2024 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| LIB Therapeutics LLC | For profit | MKTG | Dec 12, 2025 |