Table 1.
Summary of Advanced Therapies in Phase II/III for the Management of Ulcerative Colitis
| Drug Class | Agent | Target | Mode of Delivery | Stage |
|---|---|---|---|---|
| Anti-TNF | CT-P13 | TNF | SC | Phase III completed |
| OPRX-106 | TNF | Oral | Phase II completed | |
| JAK inhibitors | Ivarmacitinib | JAK1 | Oral | Phase II completed/Phase III recruiting |
| Brepocitinib (PF-06700841) | JAK1/TYK2 | Oral | Phase IIb completed | |
| Ritlecitinib (PF-06651600) | JAK3/TEC kinase inhibitor | Oral | Phase IIb completed | |
| Peficitinib | Pan-JAK (JAK3) | Oral | Phase IIb completed (No dose response relationship) | |
| Izencitinib (TD-1473) | Pan-JAK (gut selective) | Oral | Phase IIb completed (primary endpoint not met) | |
| Deucravacitinib (BMS-986165) | TYK2 | Oral | Phase II completed (primary endpoint not met) | |
| Anti-Trafficking Agents | Etrolizumab | α4β7 and αEβ7 integrins | SC | Phase III completed |
| Carotegrast methyl (AJM300) | α4 integrin | Oral | Phase III completed | |
| Ontamalimab (PF-00547659) | MAdCAM | SC | Phase II completed | |
| Abrilumab (AMG181) | α4β7 integrin | SC | Phase II completed | |
| PN-943 | α4β7 integrin (gut restricted) | Oral | Phase II completed (primary endpoint not met) | |
| PTG-100 | α4β7 integrin | Oral | Phase IIa completed (primary endpoint not met) | |
| IL-23 Inhibitors | Mirikizumab | IL23/p19 subunit | IV, SC | Phase III completed |
| Risankizumab | IL23/p19 subunit | IV, SC | Phase III completed (results pending) | |
| Brazikumab | IL23/p19 subunit | IV, SC | Development Halted | |
| Guselkumab | IL23/p19 subunit | IV, SC | Phase IIb/III active | |
| S1P Receptor Modulators | Etrasimod | S1PR1, S1PR4 and S1PR5 | Oral | Phase III completed |
| CBP-307 | S1PR1 | Oral | Phase II completed | |
| Amiselimod (MT-1303) | S1PR1 | Oral | Phase II recruiting | |
| PDE4 Inhibitors | Apremilast | PDE4 | Oral | Phase II completed |
| TLR9 Agonist | Cobitolimod | TLR9 | Topical (enema) | Phase IIb completed/Phase III recruiting |
Abbreviations: TNF, tumor necrosis factor; JAK, janus kinase; TYK 2, tyrosine kinase 2; S1P, sphingosine 1 phosphate; S1PR, sphingosine 1 phosphate receptor; PDE4, phosphodiesterase 4; TLR9, toll-like receptor 9; α4β7, alpha4-beta7; αEβ7, alphaE-beta7; α4, alpha4; MAdCAM, mucosal addressin cell adhesion molecule-1; IL-23, interleukin 23; IV, intravenous; SC, subcutaneous.