Q2 2026 preview: 4 FDA decisions to watch in pediatric care

The second quarter of 2026 will include multiple advancements in pediatric care, including 4 drugs to be discussed by the FDA that will significantly advance disease management in this population. These include inhaled insulin (Afrezza), a rapid-acting inhaled human insulin for glycemic control, and teplizumab (Tzield), a disease-modifying intervention to delay the onset of type 1 diabetes.

The FDA will also be discussing the new drug application submitted for CTx-1301 (dexmethylphenidate HCl), a once-daily formulation to remove the need for afternoon boosters in patients with attention-deficit/hyperactivity disorder, and roflumilast cream (Zoryve), a therapy with favorable safety and efficacy against plaque psoriasis. Below is a recap of upcoming FDA decisions, with links to related coverage from the MJH Life Sciences family of brands.

1. Inhaled insulin (Afrezza; MannKind Corporation)¹
Date: May 29, 2026
Indication: To improve glycemic control in children and adolescents aged 4 to 17 years living with type 1 or type 2 diabetes.

Background: Based on dedicated pediatric data from the 26-week phase 3 INHALE-1 trial (NCT04974528), the application evaluates this rapid-acting inhaled human insulin combined with basal insulin vs multiple daily injections in patients aged 4 to 17 years. If approved, this formulation would introduce a needle-free mealtime insulin delivery option for patients 4 years and older, providing a practical alternative to multiple daily injections and pump therapy that could simplify administration in school and caregiving settings. The supplemental biologics license application was accepted on October 13, 2025.

Related coverage: FDA accepts inhaled insulin (Afrezza) sBLA for pediatric diabetes

2. Teplizumab (Tzield; Sanofi)²
Date: April 29, 2026
Indication: To delay the onset of type 1 diabetes in adults and pediatric patients aged 8 years and older who are at high risk.

Background: Based on the TN-10 phase 2 study (NCT01030861), which directly enrolled a combined population of adults and children aged 8 to 45 years rather than relying on extrapolated adult data, a single 14-day course of the therapy delayed the median time to clinical diagnosis of stage 3 disease by approximately 2 years compared with placebo (48.4 months vs 24.4 months). This provides pediatric practitioners with the first proactive, disease-modifying intervention to protect beta-cell function in high-risk patients aged 8 years and older, recognizing a clinical gap as the treatment remains unapproved and off-label for children younger than 8 years. The supplemental biologics license application was accepted on January 5, 2026.

Related coverage: FDA accepts Tzield sBLA for stage 2 type 1 diabetes in children as young as 1 year

3. CTx-1301 (dexmethylphenidate HCl; Cingulate Inc)³
Date: May 31, 2026
Indication: The treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients 6 years and older.

Background: Based on a dedicated pediatric phase 3 fixed-dose study in children 6 years and older, the investigation demonstrated dose-dependent improvements on the ADHD-RS-5 and CGI-I scales using a multicore Precision Timed Release tablet. This once-daily formulation is designed to provide rapid onset and active-day duration to eliminate afternoon booster doses. The new drug application was accepted on October 14, 2025.

Related coverage: FDA accepts NDA for CTx-1301 for treatment of ADHD

4. Roflumilast cream (Zoryve; Arcutis Biotherapeutics)⁴
Date: June 29, 2026
Indication: The topical treatment of plaque psoriasis in children aged 2 to 5 years.

Background: Based on dedicated pediatric data from a 4-week Maximal Usage Systemic Exposure study and a long-term open-label trial in children aged 2 to 5 years, the once-daily 0.3% topical formulation demonstrated persistent efficacy alongside a consistently favorable long-term safety and tolerability profile. This would expand the therapy's current indication for patients 6 years and older, adding a steroid-free option to the pediatric armamentarium that is gentle enough for sensitive facial and intertriginous skin in early childhood. The supplemental new drug application was accepted on November 17, 2025.

Related coverage: FDA accepts sNDA for roflumilast cream 0.3% in children ages 2 to 5 with psoriasis

References

1. MannKind announces U.S. FDA accepts for review its supplemental biologics license application (sBLA) for inhaled insulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes. News release. MannKind Corporation. October 13, 2025. Accessed March 30, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental
2. Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes. News release. Sanofi. January 5, 2026. Accessed March 30, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-05-06-00-00-3212420
3. Childress A, Brams M, Koehn K, Cattaneo M, Silva R. A phase 3, dose-optimized, double-blind, randomized, placebo controlled, single-center, parallel efficacy and safety laboratory classroom study in adults with attention-deficit/hyperactivity disorder (ADHD) using CTx-1301 (dexmethylphenidate): effect size assessment. Poster presented at: American Professional Society of ADHD and Related Disorders Annual Meeting; January 15-18, 2026; San Diego, CA. Accessed March 30, 2025. https://www.cingulate.com/static-files/b3c901ad-8d47-4ebc-b0a8-41c7330bc1b6
4. 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. Arcutis Biotherapeutics. November 17, 2025. Accessed March 30, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-accepts-supplemental-new-drug-application-arcutis-zoryver