Lanadelumab

Generic Name
Lanadelumab
Brand Names
Takhzyro
Drug Type
Biotech
Chemical Formula
-
CAS Number
1426055-14-2
Unique Ingredient Identifier
2372V1TKXK
Background

Lanadelumab, also known as DX-2930, is a human IgG1 monoclonal antibody designed for subcutaneous self-injection. It is a fully human immunoglobulin, k-light-chain made in recombinant Chinese Hamster Ovary cells. The FDA and EU granted the designation of priority review, breakthrough therapy and orphan drug for rare diseases based on the results of the repor...

Indication

Lanadelumab is indicated for the prophylaxis treatment to prevent attacks in adult and pediatric patients aged 2 years and older with hereditary angioedema.
...

Associated Conditions
Acute attacks of hereditary angioedema, Recurrent Angioedema
Associated Therapies
-

A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2022-07-15
Last Posted Date
2024-12-13
Lead Sponsor
Takeda
Target Recruit Count
20
Registration Number
NCT05460325
Locations
πŸ‡¨πŸ‡³

Yantai Yuhuangding Hospital, Yantai, Shandong, China

πŸ‡¨πŸ‡³

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China

πŸ‡¨πŸ‡³

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

and more 1 locations

A Survey of Lanadelumab in Participants With Hereditary Angioedema

Recruiting
Conditions
Interventions
First Posted Date
2022-05-31
Last Posted Date
2024-07-25
Lead Sponsor
Takeda
Target Recruit Count
100
Registration Number
NCT05397431
Locations
πŸ‡―πŸ‡΅

Takeda selected site, Tokyo, T, Japan

Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-04-19
Last Posted Date
2024-04-17
Lead Sponsor
St Vincent's Institute of Medical Research
Target Recruit Count
48
Registration Number
NCT04848272
Locations
πŸ‡¦πŸ‡Ί

St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia

Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

First Posted Date
2020-10-19
Last Posted Date
2022-06-29
Lead Sponsor
Amgen
Target Recruit Count
515
Registration Number
NCT04590586
Locations
πŸ‡ΊπŸ‡Έ

The University of Iowa, Iowa City, Iowa, United States

πŸ‡ΊπŸ‡Έ

Sharp Chula Vista Medical Center, Chula Vista, California, United States

πŸ‡·πŸ‡Ί

SPb SBIH "Alexandrovskaya City Hospital", Saint Petersburg, Russian Federation

and more 56 locations

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-08-07
Last Posted Date
2022-03-07
Lead Sponsor
Takeda
Target Recruit Count
12
Registration Number
NCT04503603
Locations
πŸ‡ΊπŸ‡Έ

Celerion, Lincoln, Nebraska, United States

Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2020-07-07
Last Posted Date
2020-10-12
Lead Sponsor
Shire
Registration Number
NCT04460105

A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-06-24
Last Posted Date
2024-06-17
Lead Sponsor
Shire
Target Recruit Count
73
Registration Number
NCT04444895
Locations
πŸ‡ΊπŸ‡Έ

Optimed Research, LTD, Columbus, Ohio, United States

πŸ‡­πŸ‡Ί

Semmelweis Egyetem, Budapest, Hungary

πŸ‡³πŸ‡±

Universitair Medisch Centrum Groningen, Groningen, Netherlands

and more 32 locations

Lanadelumab in FXII-associated Cold Autoinflammatory Syndrome (FACAS)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-02-20
Last Posted Date
2024-01-08
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
4
Registration Number
NCT04278885
Locations
πŸ‡©πŸ‡ͺ

Charite University, Berlin, Germany, Berlin, Germany

A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-12-20
Last Posted Date
2023-12-27
Lead Sponsor
Takeda
Target Recruit Count
77
Registration Number
NCT04206605
Locations
πŸ‡ΊπŸ‡Έ

University of South Florida Asthma, Allergy & Immunology, Tampa, Florida, United States

πŸ‡©πŸ‡ͺ

Universitaetsklinikum Leipzig AoeR, Leipzig, Sachsen, Germany

πŸ‡ΊπŸ‡Έ

Medical Research of Arizona, Scottsdale, Arizona, United States

and more 42 locations

Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-11-27
Last Posted Date
2022-09-30
Lead Sponsor
Shire
Target Recruit Count
12
Registration Number
NCT04180163
Locations
πŸ‡―πŸ‡΅

Kobe University Hospital, Kobe-shi, Hyogo-Ken, Japan

πŸ‡―πŸ‡΅

Asahi General Hospital, Asahi-shi, Chiba-Ken, Japan

πŸ‡―πŸ‡΅

Ogaki Municipal Hospital, Ogaki-shi, Gifu-Ken, Japan

and more 9 locations
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