11-Dec-2025
Anticipated Drug Launches for 2026
Summary
2026 looks set to be a landmark year for therapeutics as late‑stage programs convert into global regulatory filings and commercial launches. Advances span neurology, immunology, cardiology, oncology, metabolic disease and rare genetic disorders, driven by targeted biologics, next‑generation cell and gene therapies, and improved small‑molecule and peptide agents. Expect broader access via biosimilars and formulation innovations (e.g., subcutaneous and oral versions), faster patient impact from accelerated pathways, and shifting treatment paradigms as pivotal trial successes translate into regionally staggered approvals and rapid market rollout.- Author Company: PharmiWeb
- Author Name: PharmiWeb Editor.
Editor: PharmiWeb Editor
Last Updated: 11-Dec-2025
Drug / Asset
Developer
Indication
Expected region(s)
Concise regulatory status
Pivotal trial
| Oveporexton | Takeda | Narcolepsy (orexin‑2 agonist) | US, EU, JP | Phase III completed; filings expected/under review in major markets | TONES 3 (phase III program — e.g., TONES trials) |
| Donanemab | Eisai/Biogen | Early Alzheimer’s disease | US, EU, JP | FDA accelerated/standard pathway progress; EMA/PMDA reviews anticipated | TRAILBLAZER‑ALZ 2 |
| Efgartigimod SC | argenx | Generalized myasthenia gravis (SC) | Global | SC formulation regulatory submissions planned following IV approvals | ADAPT (ADAPT‑1/2 pivotal program) |
| Mavacamten | Bristol Myers Squibb | Obstructive hypertrophic cardiomyopathy | US, EU, JP | Approved in some regions; label expansions/alternative formulations anticipated | EXPLORER‑HCM (and VALOR‑HCM for septal reduction outcomes) |
| Abrocitinib | Pfizer | Moderate‑to‑severe atopic dermatitis | Global | Approved in several markets; additional approvals/label refinements expected | JADE pivotal program (e.g., JADE MONO‑1/MONO‑2) |
| AXS‑05 | Axsome | Major depressive disorder | US, EU | NDA/MAA filings progressing; potential approvals in 2026 | ASCEND / GEMINI / other phase III trials (AXS‑05 program) |
| Avacopan | ChemoCentryx / Vifor | ANCA‑associated vasculitis | Global | Approved in some regions; additional launches/label updates expected | ADVOCATE |
| Voclosporin | Aurinia | Lupus nephritis | US, EU | Approved in some markets; broader launches or new indications planned | AURORA 1 (pivotal) |
| Aducanumab (label/availability) | Biogen / Eisai | Alzheimer’s disease (anti‑amyloid) | Select markets | Market availability varies; regional label/coverage changes possible | EMERGE / ENGAGE (phase III), plus ongoing real‑world studies |
| Epcoritamab | Genmab / AbbVie | B‑cell non‑Hodgkin lymphoma | US, EU, JP | Rolling approvals; expanded indications and commercial launches expected | EPCORE NHL‑1 (pivotal) |
| Tafasitamab + Lenalidomide (combo) | MorphoSys / Incyte / partners | Relapsed/refractory DLBCL | US, EU | Regulatory expansions and reimbursement negotiations ongoing | L‑MIND |
| Next‑gen CAR‑Ts (multiple) | Various (large biotech/pharma) | Hematologic malignancies (and beyond) | US, EU | Several allogeneic/in‑vivo CAR‑T candidates in late‑stage; first launches possible | Multiple pivotal trials (e.g., ALPHA, UNIVERSAL, INVEGA‑style program names vary) |
| Gene therapies (selected) | Various (specialty biotechs) | Rare inherited retinal, metabolic, neuromuscular diseases | US, EU, JP | Pivotal readouts completed or expected; selective approvals forecast | Multiple named pivotal studies (program‑specific: e.g., INDIGO, VTX‑series) |
| New GLP‑1 / dual agonists | Multiple (big pharma + biotech) | Obesity, type 2 diabetes | Global | Late‑stage programs with anticipated regulatory submissions and 2026 launches | SURMOUNT‑style or SELECT‑style pivotal programs (program names vary by asset) |
| High‑impact biosimilars | Multiple manufacturers | Oncology, immunology biologics | Global | Multiple biosimilars expected to gain approval and market entry in 2026 | Regulatory submissions supported by equivalence/non‑inferiority pivotal studies (trial names vary) |
Editor's Note: This is not an exhaustive list
