2026 Drugs to Watch: New Approvals and Expanded Indications

PSG’s 2026 Drugs to Watch List: A Guide For Payers

Key Points:

• PSG produces a focused list of new drugs expected to have the potential for significant impact to pharmacy budgets if approved in the upcoming year
• Nine of the eleven drugs on PSG’s 2025 Drugs to Watch List received FDA approval before the end of the year
• Six new drugs from PSG’s 2026 Drugs to Watch List have already been approved in 2026; three seeking expanded indications have also been approved
• Understanding potential financial impacts of the drug pipeline helps inform strategic decisions and optimize investment in pharmacy benefits

Managing drug spend and trend continues to be a major challenge for payers, with specialty drug trend near double digits according to our latest State of Specialty Spend & Trend Report. The drug pipeline represents significant advances in science as well as substantial financial investments by drug manufacturers to bring new drugs to market, which can often result in high costs for payers and patients.

As we continue through 2026, understanding the drug pipeline and its potential impact on the market remains crucial for effective drug spend management. In this article, we’ll review 2025’s notable drugs and their impact, outline our process for identifying important emerging therapies, and walk through several of the current drugs in the pipeline that we believe will be most important for payers to monitor throughout the remainder of the year.

Pipeline Developments Shape Benefit Strategies

Ongoing scientific advancements and investments are leading to groundbreaking treatments for previously untreated diseases, and enhanced formulations are offering less frequent dosing or more desirable dosage forms. We have observed consistent growth in novel drug approvals over the past decade, with specialty drugs representing more than half of all approvals and, more recently, approaching 70% or more. In 2025, 35 of the 46 (76%) novel drugs approved by the FDA’s Center for Drug Evaluation and Research (CDER) were specialty drugs.

These innovations include new therapies (some in competitive markets) offering clinical advantages such as improved efficacy, dosing frequency, or route of administration or reduced side effects. In addition, the FDA continues to review existing drugs developed in new dosage forms and expanded indications.

PSG’s Drugs to Watch List

Our proprietary Drugs to Watch List serves as an abbreviated pipeline summary of new drugs and expanded indications, both specialty and non-specialty, that we expect to have the potential for significant impact on pharmacy budgets if approved in the upcoming year. We focus on non-oncology scientific advancements that may possess a variety of the following attributes: a new high-cost drug, a new drug for a previously untreated disease, a new drug in a competitive therapeutic market offering a clinical advantage, and notable cell and gene therapies.

2025 Drugs to Watch

For 2025, our Drugs to Watch List contained 11 drugs, nine of which received FDA approval before the end of the year and have already demonstrated an impact on payer decisions. Notable 2025 approvals included:

• Journavx, a first-in-class non-opioid analgesic that represents the first significant innovation in pain medication in more than 20 years
• Three new orphan drugs for the management of hereditary angioedema (HAE), including Ekterly, the first oral drug for treatment of acute HAE attacks, and two subcutaneous injectable drugs, Andembry and Dawnzera, offering less frequent dosing for prevention of HAE attacks
• Cardamyst, a self-administered nasal spray that is a first-of-its-kind, on-demand treatment for abnormally fast heart rate (PSVT, paroxysmal supraventricular tachycardia), designed for at-home use

Expanded indications for already approved drugs have also been a considerable driver of specialty drug trend. Our 2025 Drugs to Watch Expanded Indication List contained 10 drugs, eight of which received FDA approval. Notable approvals included:

• Wegovy, which became the first GLP-1 approved for the treatment of MASH (metabolic dysfunction-associated steatohepatitis) and the second drug FDA-approved for MASH
• Dupixent, which became the second biologic approved for the treatment of chronic spontaneous urticaria (CSU) and is expected to compete with Xolair
• Nucala, which joined Dupixent in receiving approval for the treatment of COPD (chronic obstructive pulmonary disease) with an eosinophilic phenotype
• Leqembi IQLIK, used for the treatment of Alzheimer’s disease, which was approved as a subcutaneous auto-injector for once-weekly use following completion of 18 months of IV-administered Leqembi

2026 Drugs to Watch

After reviewing a very robust drug pipeline, we selected 19 drugs for the 2026 list. So far in 2026, six of our selected drugs have already been FDA-approved.

• Exdensur, a long-acting subcutaneous injectable for the treatment of eosinophilic asthma that offers administration every six months compared to every four or eight weeks for its competitors
• Myqorzo, an oral drug used for the treatment of a genetic heart condition, obstructive hypertrophic cardiomyopathy (oHCM), which is expected to compete with Camzyos
• Yuviwel, a once-weekly subcutaneous injection that received accelerated approval to increase linear growth in children with achondroplasia
• Icotyde, the first oral IL-23 inhibitor which offers efficacy comparable to injectable biologics and is expected to compete with Skyrizi and Tremfya
• Awiqli, Novo Nordisk’s once-weekly basal insulin, the first once-weekly basal insulin to enter the market, offering a better dosing option for patients with type 2 diabetes. Eli Lilly’s once-weekly insulin candidate, efsitora alfa, is still awaiting approval.
• Eli Lilly’s Foundayo (orforglipron) was FDA approved on April 1^st. This is the second oral GLP-1 on the market, offering more favorable bioavailability without intake restrictions for food, water, or timing.

Additional notable drugs expected to receive approval this year in our abbreviated pipeline include:

• Enlicitide: The first potential oral PCSK9 inhibitor, which met its primary and key secondary endpoints in Phase 3 clinical trials, demonstrating potential for further LDL-C reductions
• Oveporexton: A first-in-class, investigational oral orexin receptor 2 (OX2R) agonist targeting the root cause of narcolepsy type 1 by restoring orexin signaling. Two other potential drugs for narcolepsy are also included in our list.
• Pegadricase: An IV-administered treatment for chronic refractory gout expected to compete with Krystexxa
• Tavapadon: An oral, once-daily dopamine agonist for Parkinson’s disease designed to offer improved motor control with a potential for fewer side effects

For our full list, please reach out to set up a discussion.

2026 Drugs to Watch, Expanded Indications

Expanded indications continue to be a key driver of drug trend. As a result, we have developed a list of 14 drugs to watch that have been submitted to the FDA seeking expanded indications. Three have already been approved:

• Dupixent received its ninth FDA-approved indication for treatment of allergic fungal rhinosinusitis (AFRS) in patients age 6 and older
• Sotyktu received FDA approval to treat adults with psoriatic arthritis (PsA), making it the first tyrosine kinase 2 (TYK2) inhibitor for PsA
• Wegovy HD, offers a higher dose for patients who have tolerated the previous highest dose but are still seeking additional weight loss

Other notable examples included in our list:

• Rinvoq, an oral JAK inhibitor is seeking approval for non-segmental vitiligo with potential to be the first JAK inhibitor approved for this condition
• Lumryz, a once-nightly, extended-release oral sodium oxybate suspension, already approved for excessive daytime sleepiness in narcolepsy, is seeking approval for excessive daytime sleepiness associated with idiopathic hypersomnia, a condition that can be difficult to diagnose
• Leqembi IQLIK, a once-weekly subcutaneous auto-injector for Alzheimer’s disease, is seeking FDA approval for use as initiation therapy, which could make dosing easier for patients and caregivers

For our full list, please reach out to set up a discussion.

Ongoing 2026 Pharmacy Benefits Strategy

As science continues to advance, we remain committed to supporting our clients in making informed coverage decisions. Our Drugs to Watch Lists continue to be a valuable tool, helping you anticipate market shifts, prepare for new therapies, and stay ahead of expanded indications for existing treatments.

We deliver the Drugs to Watch Lists to clients each January and refresh them monthly as FDA reviews progress and approvals occur. When a drug is approved, we share the key clinical and coverage considerations, along with practical utilization management recommendations. To support budget planning, we also use our proprietary data and analytics platform, Artemetrx, to identify the number of members with diagnoses aligned to new indications, helping you assess potential impact in the context of your own population. These insights often prompt clinical strategy and drug class reviews to support appropriate access and optimal use.

Understanding the financial implications of the drug pipeline can help inform smarter strategic decisions and strengthen your investment in pharmacy benefits. If you would like a deeper review of any drugs highlighted in this list and what they could mean for your plan, our team is available to help.