Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as synthetic human hepcidin
LJPC-401 · 1 trial · 1 indication
Percentage change in transferrin saturation (TSAT) as measured by blood laboratory tests.
| Arm | Type | Description |
|---|---|---|
| LJPC-401 | ACTIVE_COMPARATOR | LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial |
| Placebo | PLACEBO_COMPARATOR | 0.9% Sodium Chloride Injection, USP, or equivalent |
| Name | Type | Description |
|---|---|---|
| LJPC-401 | DRUG | LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg. |
| Placebo | DRUG | 0.9% Sodium Chloride Injection, USP, or equivalent |
Inclusion Criteria: 1. Patients with clinical diagnosis of hereditary hemochromatosis 2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis 3. Patients with serum ferritin and TSAT levels above treatment guidelines 4. Female patients of child bearing pote...
LJPC-401 is being developed for the treatment of iron overload in adult patients with hereditary hemochromatosis. Hereditary hemochromatosis is a rare disease in which excess iron accumulates in the body. LJPC-401 is an investigational small molecule and has not been approved for commercial use.
LJPC-401 is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva is the company responsible for the clinical development program for LJPC-401 in hereditary hemochromatosis.
LJPC-401 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
LJPC-401 has been studied in one completed Phase 2 trial, NCT03395704, titled A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis. The trial enrolled 70 adults across the United States, Australia, France, and the United Kingdom and was placebo-controlled and randomized.
No. LJPC-401 is an investigational drug in Phase 2 clinical development and has not been approved by the FDA. It is being studied for iron overload in adult patients with hereditary hemochromatosis, and its only listed trial, NCT03395704, has been completed.