Several regulatory decisions expected in 2026 may introduce new treatment options across high-impact areas in primary care, including type 2 diabetes, obesity, hypertension, smoking cessation, dermatology, and attention-deficit/hyperactivity disorder (ADHD). These investigational therapies span both first-in-class mechanisms and novel formulations of existing drug classes, with potential implications for prescribing patterns and patient adherence.

Below is a curated overview of 5 therapies under FDA review or advancing toward potential approval, with decisions anticipated in the coming months.

Orforglipron for Obesity Treatment

Projected Action Date: April 10, 2026

In October, Eli Lilly announced positive topline phase 3 results from the ACHIEVE-2 and ACHIEVE-5 clinical trials evaluating orforglipron, an investigational once-daily oral GLP-1 receptor agonist, for glycemic control in adults with type 2 diabetes inadequately controlled on current therapy. Based on these trials, orforglipron reduced HbA_1c by up to 1.7% versus 0.8% with the SGLT2 inhibitor dapagliflozin in patients on metformin (ACHIEVE-2), and by up to 2.1% vs 0.8% with placebo when added to basal insulin (ACHIEVE-5) — roughly double to triple the comparator effect at 40 weeks. Orforglipron is not yet FDA-approved, but if cleared, it would offer an oral GLP-1 option that outperforms a commonly used SGLT2 inhibitor and adds meaningful glycemic benefit on top of basal insulin. Gastrointestinal side effects were the most common adverse events and generally mild to moderate; notably, no hepatic safety signal was observed, which is a relevant reassurance for a small-molecule oral agent in this class.¹

Cytisinicline for Smoking Cessation

Projected Action Date: June 20, 2026

On November 3, 2025, Achieve Life Sciences announced key NDA review milestones for cytisinicline, an investigational plant-based oral therapy for smoking cessation in adults, with an FDA decision expected by June 20, 2026. The NDA is supported by two completed phase 3 trials and a long-term open-label safety study (ORCA-OL) in which 334 participants completed one full year of treatment — exceeding FDA's safety data threshold — with adverse events mostly mild and no treatment-related serious adverse events identified by the independent safety monitoring committee. If approved, cytisinicline would be the first new FDA-cleared smoking cessation treatment in nearly two decades, offering a potential new option alongside varenicline and nicotine replacement therapy. A future vaping cessation indication is also under development, though that approval remains further away.²

Baxdrostat for Hard-to-Control Hypertension

Projected Action Date: Q2 2026

On December 2, 2025, AstraZeneca announced the FDA accepted its NDA for baxdrostat under Priority Review for adults with hard-to-control hypertension, including treatment-resistant cases, with a decision expected in Q2 2026. Based on the phase 3 BaxHTN trial, a double-blind, placebo-controlled study of 796 patients already on standard antihypertensive therapy, baxdrostat 2 mg produced a placebo-adjusted systolic blood pressure reduction of 9.8 mmHg at 12 weeks, a clinically meaningful effect in a population where further BP lowering is notoriously difficult to achieve. For primary care clinicians managing patients whose blood pressure remains uncontrolled despite 3 or more medications including a diuretic, baxdrostat — if approved — would represent the first drug in a new class (aldosterone synthase inhibitors) available for this indication, offering a targeted add-on option without the need for specialist referral in most cases. Adverse events were mild and consistent with the drug's mechanism; because baxdrostat selectively inhibits aldosterone production without affecting cortisol, the risk of adrenal suppression seen with older agents in this pathway appears low, though prescribers should monitor for hyperkalemia given the aldosterone-lowering effect.³

Roflumilast Cream 0.3% to Treat Plaque Psoriasis in Children Aged 2 to 5 Years

Projected Action Date: June 29, 2026

On November 17, 2025, Arcutis Biotherapeutics announced the FDA accepted a supplemental NDA for roflumilast cream 0.3% (Zoryve) to expand its plaque psoriasis indication to children aged 2 to 5 years, with a decision expected by June 29, 2026. The submission is supported by a maximal usage systemic exposure study and a long-term open-label safety study in this age group, both demonstrating favorable tolerability — a particularly relevant finding given that this population is prone to systemic absorption through thin and intertriginous skin where psoriasis commonly appears. Roflumilast cream is already approved for ages 6 and up, so this would close a meaningful gap in the 2–5 age range where long-term topical steroid use carries the greatest concern for skin atrophy and systemic effects.⁴

CTx-1301 for Attention-Deficit/Hyperactivity Disorder (ADHD) Treatment

Projected Action Date: May 31, 2026

On October 14, 2025, Cingulate Inc. announced the FDA accepted its NDA for CTx-1301 (dexmethylphenidate), a novel once-daily formulation for ADHD in children aged 6 and older and adults, with a decision expected by May 31, 2026. Based on phase 3 trials in both adults and children, CTx-1301 demonstrated large effect sizes on validated ADHD symptom scales throughout the day, with no serious treatment-emergent adverse events — and its tolerability profile was consistent with other long-acting methylphenidate products. If approved, CTx-1301 would offer clinicians a once-daily dexmethylphenidate option engineered to deliver three timed releases across the active day, potentially addressing the midday symptom rebound and afternoon coverage gaps that are common complaints with existing extended-release stimulants. As a Schedule II controlled substance in the stimulant class, standard prescribing considerations apply, including monitoring for cardiovascular effects, growth in pediatric patients, and misuse potential.⁵

References:

1. Eli Lilly. Lilly's oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes. News release. Lilly. October 15, 2025. Accessed March 27, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-superior-glycemic
2. Achieve Life Sciences. Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation. News release. November 3, 2025. Accessed March 27 2026. https://achievelifesciences.com/achieve-meets-key-milestones-advancing-cytisinicline-nda-for-smoking-cessation/
3. AstraZeneca. Baxdrostat new drug application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension. News release. December 2, 2025. Accessed March 27, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2025/Baxdrostat-New-Drug-Application-accepted-under-FDA-Priority-Review-in-the-US-for-patients-with-hard-to-control-hypertension.html.
4. Arcutis. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5. News release. November 17, 2025. Accessed March 27, 2026. https://www.globenewswire.com/news-release/2025/11/17/3189050/0/en/FDA-Accepts-Supplemental-New-Drug-Application-for-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-the-Treatment-of-Plaque-Psoriasis-in-Children-Ages-2-to-5.html
5. Cingulate. FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date. News release. October 14, 2025. Accessed March 27, 2026. https://www.globenewswire.com/news-release/2025/10/14/3166151/0/en/FDA-Accepts-Cingulate-s-New-Drug-Application-for-CTx-1301-in-Attention-Deficit-Hyperactivity-Disorder-ADHD-and-sets-a-May-31-2026-PDUFA-Date.html