Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phase 2 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| JNJ-40346527 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Phase 1, Cohort 1 | DRUG | Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily. |
| Phase 1, Cohort 2 | DRUG | Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily. |
| Phase 1, Cohort 3 | DRUG | Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily. |
| Phase 1, Cohort 4 | DRUG | Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily. |
| Phase 2 | DRUG | JNJ-40346527 at the recommended dose determined in Phase 1 |
Inclusion Criteria: \- Patients with histopathologically confirmed initial diagnosis of Hodgkin lymphoma and who have disease that has relapsed or is refractory that is progressing or active and requires treatment after at least 1 appropriate therapy Exclusion Criteria: * Known brain metastases o...
Formulation 2 is an investigational small molecule being studied in healthy participants and in patients with relapsed or refractory Hodgkin Lymphoma. It is developed by Johnson & Johnson (JNJ) and is currently in Phase 1 clinical development.
Formulation 2 is developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting Phase 1 trials to evaluate the drug in healthy participants and in patients with relapsed or refractory Hodgkin Lymphoma.
Formulation 2 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA. It has received FDA designations including Breakthrough Therapy, Fast Track, and Priority Review.
Formulation 2 has one completed Phase 1 trial, NCT01572519, which studied JNJ-40346527 in 21 patients with relapsed or refractory Hodgkin Lymphoma in France and Germany. Another completed trial, NCT02117505, evaluated the relative bioavailability of two tablet formulations in 20 healthy adults in Belgium.
Formulation 2 is associated with the compound JNJ-40346527, which was studied in the Phase 1 trial NCT01572519 for relapsed or refractory Hodgkin Lymphoma. The drug is also linked to JNJ-54781532, which was evaluated in a bioavailability study in healthy participants.