Our Pipeline

Nezulcitinib, also known as TD-0903, is an investigational inhaled, lung-selective, pan JAK inhibitor. Nezulcitinib has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. The organ selectivity of nezulcitinib is demonstrated preclinically via a high lung: plasma ratio and rapid metabolic clearance resulting in low systemic exposure. Nezulcitinib is expected to intervene broadly to interrupt excessive immune activation in the airways. Delivered via nebulization, nezulcitinib may present a novel therapeutic modality to address the cytokine release syndrome that has been associated with acute lung injury.

Nezulcitinib is under investigation as a potential treatment for causes of acute hyperinflammation of the lung and the prevention or delay of lung transplant rejection.

Inhaled ALK5i is a potential first-in-class inhaled ALK5 inhibitor anti-fibrotic agent for the treatment of idiopathic pulmonary fibrosis (IPF).

Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor (NRI) in development for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH). It has high affinity for binding to norepinephrine transporters. By blocking the action of these transporters, ampreloxetine causes an increase in extracellular concentrations of norepinephrine.

Ampreloxetine showed positive four-week results from a Phase 2 study in patients with nOH, including durable improvements in patients’ disease symptom severity after four weeks of treatment with ampreloxetine, as measured by Orthostatic Hypotension Symptom Assessment Question #1 (“OHSA #1”). OHSA #1 is a measure of dizziness, lightheadedness, or the sensation of being about to black out. Ampreloxetine is currently being evaluated in a registrational Phase 3 program in patients with symptomatic nOH.