Our Pipeline

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.

TD-5202 is an investigational, gut-selective JAK3 inhibitor. Unique among the JAK family, JAK3 has a cysteine residue allowing for JAK3-selective irreversible inhibition. A Phase 1 study of TD-5202 in healthy volunteers is currently underway.

TD-8236 is an internally-discovered, lung-selective inhaled JAK inhibitor that has high affinity for each of the JAK family of enzymes. This JAK activity of TD-8236 is expected to impact a broad range of cytokines that have been associated with both Th2-high and Th2-low asthma. Many patients with both phenotypes remain symptomatic with currently available therapies, especially those with Th2-low asthma.

Importantly, TD-8236 is designed to have optimal therapeutic exposure levels within the lungs while minimizing systemic exposure following dry powder inhalation. This drug profile has the potential to improve treatment of inflammation within that organ while reducing the risk adverse events from systemic immunosuppression. TD-8236 has completed a Phase 1 biomarker study in moderate to severe asthmatics and a Phase 2 allergen challenge study in mild asthmatics.

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).