What to Watch in 2025
This year promises notable new approvals in CNS and metabolic diseases – those same areas likely to drive 2025 dealmaking and investment action. (See Table 2) In CNS, Vertex’s pain candidate suzetrigine and Sanofi’s multiple sclerosis drug tolebrutinib both make Evaluate’s list of the year’s biggest potential drug launches (see https://www.evaluate.com/thought-leadership/2025-preview/); filings are also anticipated for J&J’s depression candidate aticaprant and AbbVie’s Parkinson’s hopeful tavapadon.
Novo Nordisk is due to file semaglutide for MASH in 2025, while the runaway obesity therapy market may welcome the Danish group’s amylin analog/GLP-1 agonist combo CagriSema. Lilly’s Phase 3 “triple G” retatrutide, a GLP-1/GIP/glucagon receptor agonist, is not due to launch until late 2026, according to Evaluate consensus forecasts, but that could mean a mid-to-late 2025 filing.
Sponsor - compound
MoA/Indication
Vertex - suzetrigine
oral NaV1.8 pain signal inhibitor, filed for moderate-to-severe acute pain (PDUFA: Jan 30, 2025)
Axsome Therapeutics - AXS-07 (meloxicam/ rizatriptan)
Combination for acute migraine (PDUFA: Jan 31, 2025)
Novo Nordisk - semaglutide
GLP-1 agonist; MASH (2025 filing expected)
Novo Nordisk - CagriSema (cagrilintide/semaglutide)
Amylin analog/GLP-1 agonist; obesity (late-2025 filing expected)
J&J - aticaprant
Kappa opioid receptor antagonist; adjunctive therapy for major depressive disorder with anhedonia (2025 filing expected)
AbbVie - tavapadon
once-daily oral dopamine D1/D5 receptor partial agonist for Parkinson’s disease
Eli Lilly - retatrutide
GLP-1/GIP/glucagon receptor agonist; obesity (Phase 3, no filing timeline)