COMPANY
LIB Therapeutics
FDA-approved therapeutic company Clinical Phase 3
Trial and FDA signals
- FDA complete response letter Received an FDA complete response letter (BLA 761427, letter dated Dec 12, 2025). FDA BLA 761427 (Dec 12, 2025)
Evidence (1 event)
- Dec 12, 2025 · FDA BLA 761427
CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE LIB Therapeutics, Inc. Attention: Evan A. Stein, MD, PhD Chief Executive and Scientific Officer Cincinnati, OH (street omitted) Dear Dr. Stein: Please refer to your biologics l
- Dec 12, 2025 · FDA BLA 761427
Timeline
- Trial start Phase 3: Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia source ↗
- Trial start Phase 3: Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH source ↗
- FDA FDA New drug/biologic (novel): LEROCHOL (lerodalcibep-liga) — BLA761427, Dec 12, 2025. Applicant at approval: LIB Therapeutics, Inc. source ↗
- Trial start Phase 3: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients source ↗
- Trial start Phase 3: Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product source ↗
- Trial start Phase 3: Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction source ↗
- Trial start Phase 3: Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction source ↗
- Trial start Phase 3: Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction source ↗
- Trial start Phase 3: Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients source ↗
- Trial start Phase 3: Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction source ↗
- Trial start 3: Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH source ↗
- Trial start Phase 2: Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 source ↗
- Trial start Phase 2: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction source ↗
- Trial start Phase 1: Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003 source ↗
Upcoming milestones
- Jul 31, 2028 (ESTIMATED) · Phase 3 · Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH · NCT07102511
- Jul 31, 2031 (ESTIMATED) · Phase 3 · Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia · NCT07775339
Clinical trials (lead sponsor) 13
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04797104 | Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction | Phase 3 | Completed | Apr 22, 2021 | Jul 30, 2023 (actual) |
| NCT07775339 | Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia | Phase 3 | Not yet recruiting | Jan 20, 2027 | Jul 31, 2031 (estimated) |
| NCT07102511 | Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH | Phase 3 | Enrolling by invitation | Jul 20, 2026 | Jul 31, 2028 (estimated) |
| NCT05004675 | Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients | Phase 3 | Completed | Jun 20, 2022 | May 30, 2024 (actual) |
| NCT04798430 | Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction | Phase 3 | Enrolling by invitation | Dec 3, 2020 | Jul 30, 2025 (estimated) |
| NCT04797247 | Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction | Phase 3 | Unknown status (ClinicalTrials.gov) | Apr 22, 2021 | Nov 15, 2023 (actual) |
| NCT04806893 | Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction | Phase 3 | Unknown status (ClinicalTrials.gov) | Apr 22, 2021 | Nov 15, 2023 (actual) |
| NCT04790513 | Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients | Phase 3 | Completed | Apr 22, 2021 | Sep 30, 2022 (actual) |
| NCT04034485 | Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH | 3 | Completed | Dec 7, 2019 | Sep 12, 2022 (actual) |
| NCT05234775 | Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product | Phase 3 | Completed | Jan 28, 2022 | Jun 30, 2022 (actual) |
| NCT03847974 | Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 | Phase 2 | Completed | Feb 14, 2019 | Apr 7, 2020 (actual) |
| NCT03549260 | Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction | Phase 2 | Completed | May 22, 2018 | Nov 9, 2018 (actual) |
| NCT03545438 | Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003 | Phase 1 | Completed | Oct 30, 2017 | May 30, 2018 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): LEROCHOL (lerodalcibep-liga) — BLA761427, Dec 12, 2025. Applicant at approval: LIB Therapeutics, Inc. source ↗
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