Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Imlygic · 1 trial · 6 indications
Feasibility is defined as ≥80% of participants receiving 4 treatments
Tolerability is defined as no participants have a DLT or SAE
| Arm | Type | Description |
|---|---|---|
| IMLYGIC | EXPERIMENTAL | 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on Days 1 and 21 of each cycle for 4 cycles (8 treatments). |
| Name | Type | Description |
|---|---|---|
| Imlygic | DRUG | intralesional administration of IMLYGIC administered on Days 1 and 21 of each cycle for 4 cycles (8 treatments). |
Inclusion Criteria: * Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1 * Must have ≥8 measureable cNFs. Histologic confirmation of tumor is not necessary in the presence of consistent clinical findings or confirmed genetic testing. A Measurable cNF is defi...
Imlygic is being studied for the treatment of cutaneous neurofibromas in adults with neurofibromatosis type 1 (NF1). It is an investigational therapy currently in Phase 1 clinical development, and it is not yet approved for this use.
Imlygic is a small molecule therapy being evaluated for NF1. The specific molecular target is not disclosed in the available information, so its mechanism of action is not described here.
Imlygic is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the drug for the treatment of cutaneous neurofibromas in NF1 patients.
Imlygic is in Phase 1 clinical development for the treatment of cutaneous neurofibromas in adults with NF1. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and tolerability.
Imlygic is being studied in a Phase 1 clinical trial with the identifier NCT07102394. This trial is currently recruiting participants in the United States and aims to enroll 10 adults with NF1 and cutaneous neurofibromas. The study is uncontrolled and not blinded.
Yes, Imlygic and IMLYGIC refer to the same drug. The clinical trial title uses the uppercase spelling IMLYGIC, while the drug name is commonly written as Imlygic. Both names refer to the same investigational therapy being developed by Amgen.