Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OK432 · 1 trial · 1 indication
Clinical success was defined as having either a complete (90% 100%) or substantial (60% 89%) reduction in lymphatic malformation (LM) volume after treatment. Response was determined using post treatment imaging studies at approximately 1 to 6 months after completion of treatment
| Arm | Type | Description |
|---|---|---|
| OK432 (Picibanil) | EXPERIMENTAL | There is no control in this study. All participants will receive the actual drug -OK432. With each injection they may receive 0.01 to 0.05mg/mL 6-12 weeks apart up to 4 injections total. |
| Name | Type | Description |
|---|---|---|
| OK432 | DRUG | OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total. |
Inclusion Criteria: To be eligible to receive OK432 immunotherapy * Patients must be ages 6 months to 17 years * Patients must have a macrocystic Lymphatic Malformation * Patients may have had surgical treatment for their Lymphatic Malformation * Patients must have an imaging study to confirm the ...
OK432 is an investigational small molecule being studied for the treatment of Lymphatic Malformations, a rare disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
OK432 is being developed by Smith & Nephew SNATS, Inc., a company listed on the stock exchange under the ticker SNN. The drug is currently in Phase 2 clinical trials for Lymphatic Malformations.
OK432 is in Phase 2 clinical development. It is an investigational drug for Lymphatic Malformations and has not been approved by the FDA. One Phase 2 trial has been completed.
OK432 has one completed clinical trial, NCT03427619, titled 'OK432 (Picibanil) in the Treatment of Lymphatic Malformations'. This Phase 2 study enrolled 275 participants in the United States, with a minimum age of 6 months.
Yes, OK432 is also known as Picibanil. The clinical trial NCT03427619 refers to the drug as 'OK432 (Picibanil)' in its title, confirming that both names refer to the same investigational treatment for Lymphatic Malformations.