Drugs / Lanadelumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Takhzyro | — | 2018-11-22 | europa.eu ↗ |
Trials 21 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04848272 | Aug 2021 → Dec 2024 | lung disorder | St Vincent's Institute of Medical Research | Unknown | No outcome recorded |
| Phase 1 | NCT04460105 | Oct 2020 → Jan 2021 | pneumonia | Shire | Withdrawn | No outcome recorded |
| Phase 1 | NCT04503603 | Aug → Dec 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03918239 | May → Nov 2019 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT03401671 | Jan → May 2018 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02093923 | May 2014 → May 2015 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01923207 | Aug 2013 → Jan 2014 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04422509 | Oct 2020 → Feb 2021 | COVID-19 | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05297786 | Jul 2022 → Sep 2024 | acute hypotension, dialysis disequilibrium syndrome | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04278885 | Oct 2020 → Dec 2024 | F12-associated cold autoinflammatory syndrome | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05460325 | Jun 2022 → Nov 2023 | hereditary angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04687137 | Feb 2021 → Jun 2022 | hereditary angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04444895 | Feb 2021 → May 2023 | angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT04590586 | Nov 2020 → Aug 2021 | COVID-19 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04206605 | May 2020 → Oct 2022 | non-histaminic angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04180163 | Dec 2019 → Aug 2021 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT04070326 | Aug 2019 → Oct 2021 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02741596 | May 2016 → Oct 2019 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02586805 | Mar 2016 → Apr 2017 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06818474 | Jun 2024 → Sep 2027 expected | acquired angioedema | Bernstein Clinical Research Center | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04583007 | — | hereditary angioedema | Shire | No longer available | No outcome recorded |
Press releases naming this drug 29 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Takeda | The European Medicines Agency (EMA) Has Approved an Additional Subcutaneous Administration Option for TAKHZYRO® (lanadelumab) for Patients Aged 12 Years and Above with Recurrent Attacks of Hereditary Angioedema (HAE) takeda.com ↗ |
| 2023-02-13 | Takeda | Takeda to Present Multiple New Data Analyses at 2023 AAAAI Annual Meeting, Including SPRING Study of TAKHZYRO ® (lanadelumab-flyo) in Pediatric Patients With Hereditary Angioedema (HAE) takeda.com ↗ |
| 2023-02-04 | Takeda | U.S. FDA Approves Takeda’s TAKHZYRO ® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older takeda.com ↗ |
| 2022-06-30 | Takeda | Takeda’s TAKHZYRO ® (lanadelumab) Demonstrated Positive Results in the Prevention of HAE Attacks in First and Only Open-Label Phase 3 Trial in Children Ages 2 to <12 Years takeda.com ↗ |
| 2022-04-12 | Takeda | TAKHZYRO ® (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to <12 Years of Age with Hereditary Angioedema (HAE) takeda.com ↗ |
| 2022-03-28 | Takeda | Takeda’s TAKHZYRO ® (lanadelumab) Approved in Japan for Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE) takeda.com ↗ |
| 2022-02-28 | Takeda | Interim Phase 4 Data Support TAKHZYRO ® (lanadelumab) as an Effective Treatment to Reduce Attacks in Hereditary Angioedema Patients takeda.com ↗ |
| 2021-08-05 | Takeda | Final Results from the Longest Hereditary Angioedema Study of Active Treatment Duration Conducted to Date Support the Sustained Safety and Efficacy of TAKHZYRO® (lanadelumab) Injection for Long-Term Prevention of Hereditary Angioedema Attacks takeda.com ↗ |
| 2021-07-09 | Takeda | New Data from the Phase 3 HELP Study ™ Open-Label Extension Evaluating Safety and Efficacy of TAKHZYRO ® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress takeda.com ↗ |
| 2021-03-12 | Takeda | Takeda Submits New Drug Application in Japan for Lanadelumab as a Preventive Treatment for Hereditary Angioedema Attacks takeda.com ↗ |
| 2020-12-08 | Takeda | Takeda Announces Approval of TAKHZYRO ® (lanadelumab) subcutaneous injection in China for the Treatment of Hereditary Angioedema takeda.com ↗ |
| 2020-11-13 | Takeda | Final Results from the Phase 3 HELP Study ™ Open-Label Extension Support TAKHZYRO ® (lanadelumab-flyo) Injection as a Long-term Preventive Treatment Option in Patients with Hereditary Angioedema takeda.com ↗ |
| 2020-06-06 | Takeda | New Data from the Phase 3 HELP Study Open-Label Extension Evaluate the Long-Term Safety and Efficacy of TAKHZYRO ® (lanadelumab) in Reducing Hereditary Angioedema Attacks takeda.com ↗ |
| 2020-05-29 | Takeda | Takeda Receives Positive CHMP Opinion for Pre-filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for use as a Preventive Treatment for Hereditary Angioedema Attacks takeda.com ↗ |
| 2019-11-08 | Takeda | New Analyses from the Phase 3 HELP Study ™ Open-Label Extension in Hereditary Angioedema Evaluate Efficacy and Safety of TAKHZYRO ® (lanadelumab-flyo) Injection During Extended Study Treatment Period takeda.com ↗ |
| 2019-06-03 | Takeda | New Ad-hoc Analysis of Phase 3 HELP Study™ Evaluates Prevention of HAE Attacks with TAKHZYRO® (lanadelumab) During Early Treatment Phase takeda.com ↗ |
| 2018-11-30 | Takeda | Shire Receives European Approval for TAKHZYRO™ (lanadelumab) subcutaneous injection, for the Preventive Treatment of Hereditary Angioedema takeda.com ↗ |
| 2018-11-27 | Takeda | Shire plc: JAMA Publishes Complete Results of Phase 3 HELP Study™ Evaluating Lanadelumab as a Preventive Treatment for Hereditary Angioedema takeda.com ↗ |
| 2018-11-16 | Takeda | Shire Announces New HELP Study(TM) Data for Lanadelumab in Hereditary Angioedema (HAE) at 2018 ACAAI Annual Scientific Meeting takeda.com ↗ |
| 2018-10-19 | Takeda | CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks takeda.com ↗ |
| 2018-09-20 | Takeda | Santé Canada autorise TAKHZYRO(MC) (lanadelumab en injection), le premier traitement à anticorps monoclonal en son genre destiné à la prévention de crises d’angioœdème héréditaire (AOH) takeda.com ↗ |
| 2018-09-20 | Takeda | Health Canada has authorized TAKHZYRO(TM) (lanadelumab injection), a first-of-its-kind monoclonal antibody treatment for the prevention of hereditary angioedema (HAE) attacks takeda.com ↗ |
| 2018-08-23 | Takeda | Shire Announces FDA Approval of TAKHZYRO™ (lanadelumab-flyo), a First-of-its-Kind mAb Preventive Treatment for Hereditary Angioedema takeda.com ↗ |
| 2018-04-18 | Takeda | The Swiss Agency for Therapeutic Products (Swissmedic) Validates Shire’s Marketing Authorization Application (MAA) for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab takeda.com ↗ |
| 2018-03-29 | Takeda | Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab takeda.com ↗ |
| 2018-03-03 | Takeda | New Data from Pivotal Phase 3 Study Investigating Lanadelumab as a Prophylactic Treatment for Hereditary Angioedema to be Presented at 2018 AAAAI/WAO Joint Congress takeda.com ↗ |
| 2018-02-27 | Takeda | The European Medicines Agency (EMA) Grants Accelerated Assessment for Shire’s Lanadelumab Being Evaluated for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients Aged 12 Years and Older takeda.com ↗ |
| 2018-02-23 | Takeda | FDA Accepts Shire’s Biologics License Application (BLA) and Grants Priority Review for Lanadelumab for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients takeda.com ↗ |
| 2017-05-18 | Takeda | Shire’s Investigational Treatment Lanadelumab Reduces Hereditary Angioedema Monthly Attack Rate by 87% Versus Placebo in Phase 3 26-week Pivotal Trial takeda.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lanadelumab | “Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks.” PMID 29043014 ↗ Oct 201716“Lanadelumab (DX-2930) is a new kallikrein inhibitor with the potential for prophylactic treatment of hereditary angioedema with C1 inhibitor deficiency.” PMID 28225674 ↗ Feb 2017 |
| Known as | DX-2930 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01923207 ↗ |
| Known as | Lanadelumab (shp643) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545189 ↗ |
| Known as | Lanadelumab flyo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545189 ↗ |
| Known as | SHP643 | “Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE” NCT02741596 ↗ |
| Known as | TAK-743 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04687137 ↗ |
| Known as | Takhzyro | “Lanadelumab Injection [Takhzyro]” NCT05297786 ↗ |
| Action | Inhibit | “DX-2930 is a human monoclonal antibody inhibitor of plasma kallikrein” PMID 24980392 ↗ Jun 20141“Plasma kallikrein inhibitor” CHEMBL3545189 ↗ |
| Modality | Monoclonal antibody | “DX-2930 is a human monoclonal antibody inhibitor of plasma kallikrein” PMID 24980392 ↗ Jun 2014 |
| Route | Subcutaneous | “single subcutaneous administration of DX-2930 or placebo” PMID 24980392 ↗ Jun 2014 |
| Target | KLKB1 | “Plasma kallikrein inhibitor” CHEMBL3545189 ↗ |