Drugs / lerodalcibep
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed low density lipoprotein cholesterol, mild elevation of 1 milestone | |||||
| Filed | US (FDA) | — | low density lipoprotein cholesterol, mild elevation of | 2024-12-16 | “LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol” libtherapeutics.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | EU (EMA) | — | — | 2026-03-30 | “LIB Therapeutics has also submitted a Marketing Authorization Application to the European Medicines Agency” libtherapeutics.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 39 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06568471 | Nov 2024 → Feb 2026 overdue | atherosclerotic cardiovascular disease, familial hypercholesterolemia, hyperlipidemia, combined, 2 | Hasten Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05004675 | Jun 2022 → May 2024 | atherosclerotic cardiovascular disease, hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT05234775 | Jan → Jun 2022 | hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT04797247 | Apr 2021 → Nov 2023 | cardiovascular disorder, hyperlipoproteinemia | LIB Therapeutics LLC | Unknown | No outcome recorded |
| Phase 3 | NCT04790513 | Apr 2021 → Sep 2022 | cardiovascular disorder, hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT04797104 | Apr 2021 → Jul 2023 | familial hypercholesterolemia | LIB Therapeutics LLC | Completed | Met primary |
| Phase 3 | NCT04806893 | Apr 2021 → Nov 2023 | hyperlipidemia, stroke disorder | LIB Therapeutics LLC | Unknown | Met primary |
| Phase 3 | NCT04798430 | Dec 2020 → Jul 2025 overdue | atherosclerotic cardiovascular disease, familial hypercholesterolemia | LIB Therapeutics LLC | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04034485 | Dec 2019 → Sep 2022 | homozygous familial hypercholesterolemia | LIB Therapeutics LLC | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07102511 Comparator | Sep 2025 → Dec 2026 expected | familial hypercholesterolemia | LIB Therapeutics LLC | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | LIB Therapeutics LLC | Regulatory U.S. Food and Drug Administration Approves an Autoinjector Version of LEROCHOL ® (lerodalcibep-liga) and Updated Indication libtherapeutics.com ↗
U.S. Food and Drug Administration Approves an Autoinjector Version of LEROCHOL ® (lerodalcibep-liga) and Updated Indication |
| 2026-05-26 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Results from Presentations on LEROCHOL ® (lerodalcibep-liga) at the 2026 European Atherosclerosis Society Meeting in Athens, May 24-26, 2026 libtherapeutics.com ↗
A total of 43 patients with genetically confirmed HoFH completed the 72-week, open-label, extension study, with mean and absolute LDL-C reductions of 19.1% and 1.44 mmol/L (55.7 mg/dL), respectively, at the 72-week primary endpoint. |
| 2026-03-30 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Results from Presentations on LEROCHOL ® at 2026 American College of Cardiology meeting in New Orleans March 28-29, 2026 libtherapeutics.com ↗
At week 72, mean ApoB was reduced by 44% and median Lipoprotein(a) by 29% |
| 2025-05-06 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Key Results from Presentations at 2025 European Atherosclerosis Society Meeting in Glasgow May 5-6 libtherapeutics.com ↗ |
| 2024-12-16 | LIB Therapeutics LLC | Regulatory LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol libtherapeutics.com ↗
LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol |
| 2024-11-19 | LIB Therapeutics LLC | Results LIB Therapeutics Announce Positive Results from Lerodalcibep 72-Week Open-Label Extension Studies at American Heart Association 2024 libtherapeutics.com ↗
Patients consistently maintained > 60% reductions (P<0.0001) in LDL-C from baseline throughout the additional 72 weeks of OLE dosing, with no signals of attenuation, including in those on Lerodalcibep for > 2 years |
| 2024-05-29 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Positive Lerodalcibep Results from Two Phase 3 LIBerate Studies at the 92nd European Atherosclerosis Society Congress libtherapeutics.com ↗
LIB Therapeutics Announces Positive Lerodalcibep Results from Two Phase 3 LIBerate Studies at the 92nd European Atherosclerosis Society Congress |
| 2024-04-08 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep at Late-Breaking Session at American College of Cardiology 2024 libtherapeutics.com ↗
announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024. |
| 2024-03-19 | LIB Therapeutics LLC | Regulatory LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China libtherapeutics.com ↗
LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China |
| 2023-08-28 | LIB Therapeutics LLC | Results LIB Therapeutics Announces Positive Results from the Phase 3 Long-term efficacy and safety of Lerodalcibep in heterozygous familial hypercholesterolemia (LIBerate-HeFH) trial. libtherapeutics.com ↗
Monthly lerodalcibep achieved both co-primary endpoints, with statistically significant (p<0.0001) placebo adjusted reductions in mean LDL-cholesterol in the intent-to-treat population of 58.6% at Week 24 and 65.0% at the mean of Weeks 22 and 24 |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lerodalcibep | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04034485 ↗ |
| Known as | Lerochol | “monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP)” NCT07102511 ↗ |
| Known as | LIB003 | “LIB003 (lerodalcibep) Process 1” NCT05234775 ↗ |
| Action | Inhibit | “Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition” PMID 39870096 ↗ Jan 2025 |
| Modality | Protein / enzyme biologic | “Lerodalcibep, a small binding anti-PCSK9 protein (adnectin)” PMID 39870096 ↗ Jan 2025 |
| Route | Subcutaneous | “monthly lerodalcibep 300 mg (1·2 mL subcutaneous injection)” PMID 39870096 ↗ Jan 2025 |
| Target | PCSK9 | “Lerodalcibep, a small binding anti-PCSK9 protein (adnectin)” PMID 39870096 ↗ Jan 2025 |