During 2025, the FDA approved several notable new drugs and vaccines — from a novel eye drop treatment to the first new oral antibiotic class for uncomplicated urinary tract infections in decades. And looking ahead to 2026, there are several other innovative ‘firsts’ on the way that could reshape how patients manage everything from allergic reactions to diabetes and hypertension.
The common thread is not just new mechanisms, but new ways of delivering care: needle-free options, once-weekly dosing, and oral therapies that rival injectables in efficacy. Instead of simply improving existing therapies, companies are chasing new formats, new combinations, and new ways to deliver the same or better outcomes with less friction for patients.
Orforglipron
Eli Lilly’s oral GLP-1 candidate orforglipron is on track for a potential US approval in March 2026, positioning it as one of the first pills expected to match the weight-loss results of injectable GLP-1 therapies while offering distinct convenience advantages. Unlike oral semaglutide (Rybelsus, Wegovy pill), orforglipron can be taken with or without food, and doesn’t require specific timing. It has also shown strong efficacy in clinical trials, with participants losing up to 15 percent of their body weight in Phase 2 studies and about 12 percent after 72 weeks at the highest dose in the Phase 3 ATTAIN-1 trial. In diabetes trials, orforglipron reduced average blood sugar levels (A1C) by about 1.3 to 1.6 percent and helped patients lose roughly eight percent of their body weight. The FDA has also awarded the drug a National Priority Voucher, which could shorten the review process to one to two months, potentially intensifying competition in the GLP-1 class and broadening access to obesity treatment for patients who prefer pills over injections.
CagriSema
Novo Nordisk’s investigational obesity drug CagriSema, a once-weekly injectable combining the amylin analog cagrilintide with GLP-1 therapy semaglutide, is expected to face an FDA decision in 2026 and could push weight-loss results beyond what GLP-1 monotherapy has delivered. The combination targets multiple appetite-regulating pathways to reduce hunger and increase fullness, with cagrilintide acting on satiety centers in the brain and slowing gastric emptying while GLP-1 suppresses appetite and improves metabolic signaling. In clinical trials, participants lost an average of 23 percent of their starting body weight after 68 weeks, compared with around 15 percent for semaglutide alone. CagriSema is being developed not only for obesity but also for type 2 diabetes and cardiovascular risk reduction, reflecting a broader shift toward treating obesity as a chronic, multi-mechanism disease. In another study, it is being directly compared with Zepbound — a matchup that could determine whether combination therapy is the next dominant approach in obesity care. A new trial is also expected to start enrolling children as young as eight to explore its use in youth obesity and type 2 diabetes.
Anaphylm
Anaphylm (dibutepinephrine) is an epinephrine prodrug sublingual film developed by Aquestive Therapeutics for the treatment of type I allergic reactions, including anaphylaxis. The film is about the size of a postage stamp, which comes in durable packaging no larger than an average credit card. This would provide a portable, needle-free alternative to autoinjectors. It was announced on Monday that Aquestive received a Complete Response Letter (CRL) from the FDA, citing concerns with packaging. The company had received a letter from the FDA earlier in the month stating that deficiencies had been identified that precluded labeling discussions at the time, but that no final decision had been made yet. The cited concerns included issues with the packaging, such as difficulties opening the pouch and incorrect film placement, both of which are safety issues during anaphylaxis. Aquestive has made modifications and plans to rapidly conduct two parallel studies that address the packaging concerns and the impact of any of those modifications. Since no additional studies were requested by the FDA, Aquestive plans to resubmit in Q3 2026 and request rapid review. If approved, this would be the second needle-free epinephrine option in the US; neffy, a nasal spray, was approved in 2024.
Baxdrostat
AstraZeneca’s baxdrostat is an oral aldosterone synthase inhibitor being developed for aldosterone-driven, treatment-resistant hypertension, a population that remains poorly controlled despite multi-drug regimens. By selectively inhibiting CYP11B2, the enzyme responsible for aldosterone production, baxdrostat targets the hormonal driver of disease rather than blocking the mineralocorticoid receptor, potentially avoiding off-target effects seen with existing therapies such as spironolactone. In Phase 2 results published in The New England Journal of Medicine, baxdrostat produced significant reductions in systolic blood pressure in patients with resistant hypertension, supporting a more precision-based approach to blood pressure control in high-risk patients. The drug is now positioned for regulatory review, with an expected FDA decision in the second quarter of 2026, and could become the first therapy specifically approved to address excess aldosterone as a primary disease mechanism.
Awiqli
Awiqli, Novo Nordisk’s once-weekly basal insulin (insulin icodec), represents the most significant change in insulin dosing in decades, reducing injections from daily to weekly for people with diabetes. In the Phase 3 ONWARDS clinical program, insulin icodec demonstrated non-inferior or superior A1C reductions compared with daily basal insulins such as insulin glargine, with an overall safety profile that was manageable when appropriately titrated. By dramatically lowering injection burden, Awiqli could improve adherence and long-term glycemic control, particularly for patients who delay insulin initiation due to daily dosing demands. The therapy has already received regulatory approval in the EU, and an FDA decision is expected in 2026, positioning Awiqli to set a new competitive benchmark for basal insulin development and intensify innovation in a class that has seen little dosing evolution for years.
