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.

Izencitinib, also known as TD-1473, is an investigational gut-selective pan-Janus kinase (JAK) inhibitor that has demonstrated a high affinity for each of the JAK family of enzymes (JAK1, JAK2, JAK3 and TYK2). Through the inhibition of these enzymes, izencitinib interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. Importantly, as a gut-selective treatment, izencitinib is specifically designed to distribute adequately and predominantly to the tissues of the intestinal tract and to minimize systemic exposure. As such, we believe that this novel approach to JAK inhibition has the potential to treat inflammatory intestinal diseases while minimizing the risk of systemic side effects.

Izencitinib has demonstrated positive results in an exploratory Phase 1b clinical trial in patients with ulcerative colitis, including localized biological activity and minimal systemic exposure, as well as a favorable safety and tolerability profile. Izencitinib is currently in a registrational Phase 2b/3 induction and maintenance study for ulcerative colitis, as well as a Phase 2 induction study in Crohn’s disease. We have a global co-development and commercialization agreement with Janssen Biotech, Inc. for izencitinib and other back-up compounds for inflammatory intestinal diseases.

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.

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