Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-667 · 1 trial · 1 indication
An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A treatment-emergent adverse event (TEAE) was defined as any adverse event occurring after the start of Icatibant administration of the treatment period.
Injection sites were examined for erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation. Data for injection site reactions were collected separately from general reports of AEs. As pre-defined in the protocol, an injection site reaction not meeting SAE criteria was not required to be reported additionally as an AE.
| Arm | Type | Description |
|---|---|---|
| TAK-667 | EXPERIMENTAL | TAK-667, single SC administration on the abdomen on Day 1. The dose of TAK-667 will be dependent on the participant's body weight (Up to 30 mg; 10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for \>65 kg). |
| Name | Type | Description |
|---|---|---|
| TAK-667 | DRUG | TAK-667 single SC administration |
Inclusion Criteria: 1. In the opinion of the investigator or subinvestigator, the participant's parent or legal guardian is capable of understanding and complying with protocol requirements. 2. The participant's parent or the participant's legal guardian is capable of signing and dating a written i...
| 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-667 is used for the treatment of acute attacks of hereditary angioedema (HAE) in Japanese children and teenagers aged 2 years and older. It is a small molecule being developed by Takeda Pharmaceutical Company Limited for this immunology indication.
TAK-667 is a small molecule developed for hereditary angioedema. The specific molecular target is not disclosed in the available information, so its mechanism of action is not described here.
TAK-667 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this small molecule for hereditary angioedema.
TAK-667 is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for acute attacks of hereditary angioedema in Japanese pediatric patients.
TAK-667 has one completed Phase 3 trial, NCT04654351, which studied the drug in Japanese children and teenagers with acute attacks of hereditary angioedema. The trial enrolled 2 participants and was uncontrolled, non-randomized, and open-label.
TAK-667 is also known as icatibant. The completed Phase 3 trial NCT04654351 is titled 'A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema,' confirming that TAK-667 is the same compound as icatibant.