Pipeline

A humanized, affinity-optimized, afucosylated IgG1 kappa (IgG1κ) monoclonal antibody (mAb) that binds to the B cell-specific surface antigen CD19.

IgG4-Related Disease: Phase 3 trial evaluating UPLIZNA for the prevention of flare in patients with IgG4-related disease.

Myasthenia Gravis (MINT): Phase 3 trial evaluating UPLIZNA for improving outcomes in patients with myasthenia gravis.

A molecule that blocks lysophosphatidic acid receptor 1 (LPAR₁). We are conducting a Phase 2b pivotal trial in diffuse cutaneous systemic sclerosis and a Phase 2 trial in idiopathic pulmonary fibrosis.

Learn more about the HZN-825 trial in idiopathic pulmonary fibrosis here.

Learn more about the HZN-825 trial in diffuse cutaneous systemic sclerosis here.

A fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells. We are investigating dazodalibep in Sjögren's syndrome and focal segmental glomerulosclerosis as well as conducting a Phase 2 clinical trial in kidney transplant rejection. We also completed a Phase 2 randomized, placebo-controlled clinical trial that established proof of concept in rheumatoid arthritis in May 2022.

A fully human monoclonal antibody against ILT7 that depletes certain dendritic cells. We are investigating daxdilimab in lupus nephritis and in both dermatomyositis and anti-synthetase inflammatory myositis as well as conducting Phase 2 clinical trials in alopecia areata, discoid lupus erythematosus and systemic lupus erythematosus.

A monoclonal antibody against insulin-like growth factor-1 receptor (IGF-1R).

Active TED in Japan (OPTIC-J): Phase 3 randomized, placebo-controlled trial in Japan to evaluate TEPEZZA in patients with moderate-to-severe active TED.

Chronic/Low Clinical Activity Score (CAS) TED in Japan: Phase 3 randomized, placebo-controlled trial in Japan to evaluate TEPEZZA in patients with chronic/low clinical activity score (CAS) TED.

Subcutaneous Administration: Phase 1 pharmacokinetic trial to explore subcutaneous administration of TEPEZZA.

A fully human monoclonal antibody that binds and neutralizes the function of the FLT3-ligand, thereby reducing both conventional and plasmacytoid dendritic cells. We are conducting a Phase 1 trial in autoimmune diseases.

Collaboration and option agreement with Q32 Bio to develop ADX-914, a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP, two key immune pathways.

Atopic Dermatitis: Phase 2 trial being conducted by Q32 Bio to evaluate ADX-914 in atopic dermatitis.

Additional Autoimmune Disease: Phase 2 trial to be conducted by Q32 Bio to evaluate ADX-914 in a second autoimmune disease.

Horizon has an option to acquire ADX-914 from Q32 Bio on pre-negotiated terms through the completion of Phase 2 clinical trials.

Exclusive collaboration to investigate a short interfering RNA (siRNA) therapeutic targeting xanthine dehydrogenase in the liver (GalNAc), to reduce serum uric acid and treat uncontrolled gout. We are conducting a Phase 1 clinical trial in gout.

Exclusive collaboration to develop novel, multi-specific fusion protein based therapies for autoimmune and inflammatory diseases.

Exclusive collaboration to discover new therapeutics for novel gout targets by combining HemoShear’s discovery expertise with Horizon’s rheumatology development and commercialization expertise.