Five FDA drug approvals to watch in 2026

Five high-profile FDA drug approvals to watch in 2026 illustrate a broader shift toward treatments that may reduce the burden of care through oral medicines, needle-free delivery and less frequent dosing. The candidates include Eli Lilly’s oral GLP-1 drug orforglipron, Novo Nordisk’s CagriSema and once-weekly insulin icodec, AstraZeneca’s hypertension candidate baxdrostat, and Aquestive Therapeutics’ needle-free allergy treatment Anaphylm. However, regulatory timelines and approval prospects can change.

Five potential approvals to watch

The five therapies highlighted in the 2026 pipeline span obesity, diabetes, resistant hypertension and severe allergic reactions. Their common feature is not simply a new drug mechanism, but an attempt to make treatment easier for patients through new delivery methods or dosing schedules.

1. Orforglipron: An oral GLP-1 contender

Eli Lilly’s orforglipron is an investigational oral GLP-1 receptor agonist being developed for obesity and type 2 diabetes.

The drug attracted particular attention because it is designed as a pill, potentially offering an alternative for patients who prefer not to use injectable therapies. In the clinical data highlighted by Drug Discovery News, orforglipron showed substantial weight loss and reductions in glycated hemoglobin, or A1C, in diabetes studies.

The therapy was among the high-profile FDA decisions anticipated for 2026, reflecting growing competition to bring effective oral treatments into the GLP-1 market.

2. CagriSema: Combining two obesity pathways

Novo Nordisk’s CagriSema combines semaglutide, a GLP-1 therapy, with cagrilintide, an amylin analogue. The once-weekly injectable treatment is intended to target multiple biological pathways involved in appetite and satiety.

Clinical trial results have suggested that the combination could produce greater average weight loss than semaglutide alone, although the precise results and clinical significance depend on the study population and treatment regimen. The FDA decision remains an important event for the rapidly evolving obesity drug market.

3. Anaphylm: A needle-free option for severe allergic reactions

Anaphylm, or dibutepinephrine, is an investigational sublingual film designed to deliver epinephrine for the treatment of severe type I allergic reactions, including anaphylaxis.

The treatment is designed as a small film placed under the tongue, potentially offering a needle-free and portable alternative to traditional epinephrine autoinjectors. However, its regulatory path changed after the FDA issued a Complete Response Letter that raised packaging-related concerns. The developer said it planned additional work and a resubmission.

That development means Anaphylm should be viewed as a drug candidate under continued regulatory review rather than an approved therapy.

4. Baxdrostat: A new approach to resistant hypertension

AstraZeneca’s baxdrostat is an investigational oral aldosterone synthase inhibitor for uncontrolled and treatment-resistant hypertension.

The drug works by targeting CYP11B2, an enzyme involved in aldosterone production. This approach aims to address a hormonal mechanism that may contribute to high blood pressure in some patients rather than acting primarily through conventional blood pressure pathways.

Baxdrostat was among the notable FDA decisions expected in the second quarter of 2026, according to Nature Reviews Drug Discovery.

5. Awiqli: From daily insulin to weekly dosing

Novo Nordisk’s Awiqli, also known as insulin icodec, is a once-weekly basal insulin designed to reduce the number of injections required for people using basal insulin therapy.

Clinical trials in the ONWARDS program compared insulin icodec with daily basal insulin regimens and examined blood glucose control and safety. The potential advantage is primarily one of treatment convenience: reducing injection frequency from daily to weekly could help lower the burden of long-term diabetes management for some patients.

Convenience is becoming a central focus

The pipeline reflects an increasingly important trend in drug development: innovation is no longer focused only on discovering entirely new biological targets.

Pharmaceutical companies are also trying to redesign how established treatments are delivered. Oral alternatives to injections, once-weekly therapies and needle-free emergency medicines could reduce practical barriers to treatment and potentially improve adherence for some patients.

This does not mean that a more convenient formulation is automatically clinically superior. Safety, effectiveness, cost, accessibility and suitability for individual patients remain critical factors in determining the value of any new treatment.

Regulatory outlook can change

It is important to distinguish between a drug being expected to receive an FDA decision and a drug actually receiving FDA approval.

Several therapies initially identified as major 2026 candidates have faced changing timelines or additional regulatory requirements. For example, Anaphylm received a Complete Response Letter, while other candidates remain subject to ongoing FDA review.

As of August 2026, the FDA’s approved-drug records and subsequent industry reporting also show that the regulatory landscape has continued to evolve throughout the year, underscoring that early-year approval forecasts should not be treated as guarantees.

Why It Matters

FDA drug approvals in 2026 could reshape treatment by focusing on both medical innovation and patient convenience. Oral GLP-1 medicines, once-weekly insulin, targeted hypertension therapies and needle-free emergency treatments may reduce some of the practical barriers associated with long-term care. However, anticipated approvals are not guaranteed, and the ultimate clinical impact will depend on regulatory decisions, safety data, pricing and patient access.

Frequently Asked Questions

Which FDA drug approvals are being closely watched in 2026?

Among the prominent candidates are orforglipron for obesity and diabetes, CagriSema for obesity, baxdrostat for uncontrolled or resistant hypertension, Awiqli for diabetes and Anaphylm for severe allergic reactions. Their regulatory status and timelines may change.

Why is oral GLP-1 treatment attracting attention?

Oral GLP-1 therapies could offer an alternative for patients who prefer not to use injections. Their potential importance depends not only on effectiveness but also on safety, dosing requirements, affordability and access.

Is Anaphylm approved by the FDA?

Based on the regulatory update covered in the source article, Anaphylm had received a Complete Response Letter related to packaging concerns and was not approved at that point. The developer planned further studies and a resubmission.

Could once-weekly insulin replace daily insulin for everyone?

Not necessarily. Once-weekly basal insulin may reduce injection frequency, but treatment selection depends on the type of diabetes, insulin requirements, glucose control, safety considerations and individual clinical circumstances.

Sources: Drug Discovery News, Nature Reviews Drug Discovery, American Journal of Health-System Pharmacy, U.S. Food and Drug Administration