Drug Approvals to Watch in 2026

The pharma and biotech industry is set to enter 2026 after several years of rapid innovation and financial instability. 2026 may bring a wave of first-in-class therapies, novel formulations and expanded treatment options in areas ranging from obesity to cancer to neurology.

Hundreds of specialty drugs in development are expected to move toward regulatory review in 2026. Innovations in drug modalities, including oral alternatives to injectables, new biologics and more efficient drug development pipelines, are also accelerating. Next-gen versions of drugs like GLP-1 agonists are also on the horizon, set to boost an already massive market. And COVID-19 isn’t going to be forgotten as it gets packaged with influenza vaccination.

At the same time, patent expirations on older blockbuster drugs and shifts in regulation may create space for newer, more affordable medications.

Key Drugs and Therapies to Watch in 2026

Here are some of the most anticipated drug candidates and launches with potential impact next year. Some of the information/data is from Evaluate’s drug launches list.

Oveporexton

Takeda’s oveporexton is a first-in-class orexin-2 agonist being developed for the neurological sleep disorder narcolepsy. It is specifically designed for narcolepsy type 1 (NT1), which is characterized by a lack of the brain chemical orexin due to the destruction of orexin-producing neurons. Takeda shared data from two global Phase III studies for NT1 in September in which oveporexton met all primary and secondary endpoints, showing statistically significant and clinically meaningful improvements over placebo across key symptoms like excessive daytime sleepiness and cataplexy (sudden loss of muscle tone due to strong emotions like laughter, surprise or anger). Patients on the drug experienced improved wakefulness (longer sleep latency on objective wakefulness tests and lower subjective sleepiness scores), substantial reductions in weekly cataplexy episodes (median reduction of >80%), better overall disease severity scores and improved quality of life.  Takeda is planning a New Drug Application (NDA) submission to the FDA by the end of its fiscal year, which concludes in March 2026.

Bemarituzumab

Amgen’s bemarituzumab, a humanized monoclonal antibody that targets fibroblast growth factor receptor 2b (FGFR2b), is being developed to treat advanced gastric and gastroesophageal junction (G/GEJ) cancers that overexpress FGFR2b. It works by blocking FGF signaling and slowing tumor growth, and has shown promise in clinical trials (Fight and Fortitude-101) when combined with chemotherapy (mFOLFOX6), demonstrating improved progression-free survival (PFS) and overall survival (OS), though results are still being analyzed for regulatory filing. In the Phase II Fight trial, clinically meaningful improvements in PFS and OS for FGFR2b-positive GC patients when combined with mFOLFOX6 were seen. The Phase III Fortitude-101 trial in first-line G/GEJ cancer met its primary OS endpoint, but later analysis showed a decreased survival benefit, with data from Fortitude-102 pending before potential FDA filing. It has received Breakthrough Therapy designation but is still under evaluation, with data from Phase III trials guiding next steps.

CagriSema

Developed by Novo Nordisk, CagriSema is a next-gen obesity therapy that combines targeting of the GLP-1 and amylin pathways, aiming for stronger effects than older obesity drugs. The once-weekly injectable drug combines an amylin analogue (cagrilintide) and a GLP-1 agonist (semaglutide) for weight loss and improved blood sugar control in adults with obesity and type 2 diabetes. It has so far demonstrated strong results in ongoing Phase III trials (Redefine program). Results published in The New England Journal of Medicine in June 2025 showed that in the Phase IIIa Redefine trial, the mean change in body weight from baseline to Week 68 was −13.7% in the CagriSema cohort compared to −3.4% in the placebo arm. Novo Nordisk is expected to seek approval in early 2026. If approved, it may offer patients another tool in managing obesity and related metabolic conditions like its predecessors Ozempic and Wegovy.

Orforglipron

Analysts expect orforglipron from Eli Lilly could reach approval by late 2026. Newer gen GLP-1 drugs will target both weight management and metabolic disease. Orforglipron is a non-peptide, small-molecule GLP-1 receptor agonist currently in Phase III clinical trials. The investigational, once-daily oral pill is being developed for the treatment of type 2 diabetes and obesity. Phase III data published in The New England Journal of Medicine in September 2025 showed a mean change in body weight from baseline to Week 72 of −7.5% with 6 mg of orforglipron, −8.4% with 12 mg of orforglipron and −11.2% with 36 mg of orforglipron, as compared with −2.1% with placebo. Among patients in the orforglipron 36-mg group, 54.6% had a reduction of 10% or more, 36.% had a reduction of 15% or more and 18.4% had a reduction of 20% or more versus 12.9%, 5.9% and 2.8% of the patients, respectively, in the placebo group.

Zilganersen

According to its developer, Ionis Pharmaceuticals, the company’s first wholly-owned neurology medicine, zilganersen, is expected to launch in 2026. Zilganersen is a neurological treatment being developed for the rare neurological disorder, Alexander disease (AxD), a rare, progressive and often fatal neurological condition with no approved treatments. In September 2025, Ionis shared data from a pivotal Phase I-III study that showed statistically significant and clinically meaningful stabilization on the primary endpoint of gait speed as assessed by the 10-Meter Walk Test (10MWT) compared to control at Week 61, with a mean difference of 33.3%. The treatment also displayed benefit in key secondary endpoints. Ionis said these data “mark the first time an investigational medicine has shown a positive disease-modifying impact in AxD.” The company shared that it is planning to submit an NDA in the first quarter of 2026.

mRNA-1083

Moderna’s pan-respiratory vaccine (mRNA-1083) for COVID-19 and flu is a vaccine to watch out for in 2026. The key late-stage vaccine’s launch is anticipated in 2026. mRNA-1083 is a combination shot for both influenza and COVID-19, potentially simplifying the seasonal vaccination process. The company voluntarily withdrew its initial Biologics License Application (BLA) for the vaccine in May 2025 and is now targeting potential approval for 2026. Moderna also obtained $1.5 billion in financing in November 2025 to help support its pipeline and operations, giving the company a financial cushion as it faces uncertainty about future revenues.