Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-743 · 1 trial · 1 indication
TEAEs were defined as adverse events (AEs) with onset at the time of or following the first exposure to lanadelumab in this study, or medical conditions present prior to the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. Serious TEAEs were defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) that at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, important medical event. AESI were defined as investigator-reported hypersensitivity reactions, events of disordered coagulation as bleeding/hypercoagulable. Relatedness to study drug was based on Investigator's discretion. TEAEs were classified and reported as Hereditary Angioedema (HAE) attack and non-HAE attack AEs in this outcome measure.
Clinical laboratory testing included clinical serum chemistry, hematology, coagulation and urinalysis. Any change in clinical laboratory abnormalities which were deemed clinically significant by the investigator were recorded as TEAEs.
Vital signs parameters included blood pressure, heart rate, body temperature and respiratory rate. Any change in vital sign abnormalities which were deemed clinically significant by the investigator were recorded as TEAEs.
| Arm | Type | Description |
|---|---|---|
| TAK-743 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TAK-743 300 mg | DRUG | TAK-743 300 mg, subcutaneous injection every 2 or 4 weeks |
Inclusion Criteria: 1. In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements. 2. Be of Japanese descent, defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents. 3. Male and female HAE pa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
TAK-743 is a small molecule being developed for the treatment of hereditary angioedema, a rare genetic condition characterized by recurrent episodes of severe swelling. It is currently in Phase 3 clinical development and is being studied in Japanese patients with the condition.
TAK-743 is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK. The company is conducting clinical research on this investigational therapy for hereditary angioedema.
TAK-743 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, involving 12 participants with hereditary angioedema in Japan.
TAK-743 has been studied in one clinical trial with the identifier NCT04687137. This was a Phase 3 expanded access program for Japanese people with hereditary angioedema. The trial has been completed and enrolled 12 participants aged 12 years and older.
TAK-743 is associated with the drug lanadelumab, as the clinical trial NCT04687137 is titled 'Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema.' The trial was conducted in Japan and involved 12 participants with hereditary angioedema.