Drugs / CSL312
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed angioedema, hereditary, 4 2 milestones | |||||
| Filed | US (FDA) | — | angioedema, hereditary, 4 | 2023-12-14 | “the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for garadacimab (CSL312)” csl.com ↗ |
| Filed | EU (EMA) | — | angioedema, hereditary, 4 | 2023-12-14 | “the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab” csl.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Andembry | — | 2025-02-10 | europa.eu ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05306275 | Apr → Sep 2022 | — | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT04580654 | Oct 2020 → May 2021 | — | CSL Behring | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04281524 | Mar 2020 → Aug 2021 | vein disorder | CSL Behring | Withdrawn | No outcome recorded Stop: Business |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05130970 | Feb 2022 → Jan 2024 | idiopathic pulmonary fibrosis | CSL Behring | Completed | No outcome recorded |
| Phase 2 | NCT04409509 | Jul 2020 → Jan 2021 | COVID-19 | CSL Behring | Completed | Missed primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05819775 | May 2023 → Nov 2025 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT04739059 | Mar 2021 → Nov 2025 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT04656418 | Jan 2021 → Jun 2022 | hereditary angioedema | CSL Behring | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06806657 | Apr 2025 → Jun 2026 overdue | hereditary angioedema | CSL Behring | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07159464 | — | hereditary angioedema | CSL Behring | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03712228 Comparator | Oct 2018 → Oct 2021 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | CSL Behring | Results CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE) csl.com ↗
CSL (ASX:CSL; USOTC:CSLLY) today announced positive top-line Phase 3b results evaluating ANDEMBRY ® (garadacimab-gxii) in children aged 2 to 11 years with hereditary angioedema (HAE). |
| 2025-08-08 | CSL Behring | Regulatory Health Canada Has Authorized CSL's ANDEMBRY® (garadacimab) as Once-Monthly Treatment for Hereditary Angioedema (HAE) csl.com ↗
CSL (ASX:CSL; USOTC:CSLLY) today announced that Health Canada has granted a marketing authorization for ANDEMBRY® (garadacimab) for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. |
| 2025-06-16 | CSL Behring | Regulatory U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start csl.com ↗ |
| 2025-02-26 | CSL Behring | Regulatory Swissmedic Approves CSL Behring’s ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) csl.com ↗
CSL (ASX: CSL) announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to ANDEMBRY ® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. |
| 2025-02-20 | CSL Behring | Regulatory CSL Receives Approval in Japan for ANDEMBRY® (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens, a Novel Human Anti-Activated Factor XII Monoclonal Antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) csl.com ↗ |
| 2025-02-13 | CSL Behring | Regulatory European Commission Approves CSL's ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) csl.com ↗ |
| 2025-01-23 | CSL Behring | Regulatory Australia’s Therapeutic Goods Administration (TGA) Approves Registration of CSL’s ANDEMBRY® (garadacimab) for the Prevention of Recurrent Hereditary Angioedema (HAE) Attacks csl.com ↗ |
| 2024-12-13 | CSL Behring | Regulatory CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE) csl.com ↗
CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. |
| 2023-12-14 | CSL Behring | Regulatory CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance csl.com ↗ |
| 2023-03-01 | CSL Behring | Results The Lancet Publishes Pivotal Phase 3 Data on CSL's First-in-Class Garadacimab for HAE csl.com ↗
The study met its primary and secondary endpoints, demonstrating that monthly subcutaneous injections of garadacimab significantly reduced the attack rate compared to placebo in patients with HAE. |
| 2022-11-02 | CSL Behring | Results Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022 csl.com ↗
Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. |
| 2022-08-17 | CSL Behring | Results CSL Announces Positive Top-Line Phase 3 Results for Garadacimab as Preventive Treatment in Patients with Hereditary Angioedema (HAE) csl.com ↗
The study met its primary and secondary efficacy objectives and also demonstrated favorable safety and tolerability. |
| 2020-06-08 | CSL Behring | Results CSL Behring Presents Results for Garadacimab as Preventive Treatment in Hereditary Angioedema csl.com ↗
The data, presented at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress 2020, showed that the study met its primary endpoint, demonstrating reduced number of attacks compared to placebo in patients with HAE. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CSL312 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05306275 ↗ |
| Known as | Garadacimab | “Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study” NCT07159464 ↗4“Garadacimab is a fully human immunoglobulin G4 monoclonal antibody targeting activated factor XII.” PMID 38710185 ↗ May 2024 |
| Action | Inhibit | “Garadacimab (monoclonal antibody inhibiting activated factor XII [FXIIa])” PMID 42268494 ↗ Jun 2026 |
| Modality | Monoclonal antibody | “fully human immunoglobulin G4 monoclonal antibody” PMID 38710185 ↗ May 2024 |
| Route | Intravenous | “an initial intravenous loading dose” PMID 35219377 ↗ Feb 2022 |
| Target | F12 | “inhibits activated factor XII (FXIIa)” PMID 36868261 ↗ Feb 2023 |