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FDA Decisions Expected: June 2026

Your monthly synopsis of new drugs expected to hit the market 

May 15, 2026

Drug pipeline for June 2026

At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on drugs awaiting approval by the United States (U.S.) Food and Drug Administration (FDA).
June 16, 2026: ensitrelvir

Shionogi is awaiting an FDA decision on ensitrelvir, an oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease inhibitor, for post-exposure prophylaxis (PEP) of coronavirus disease of 2019 (COVID-19). The agent was granted Fast Track designation from the FDA. The global, double-blind, placebo-controlled Phase 3 SCORPIO-PEP trial was conducted between June 2023 and September 2024 and enrolled participants aged 12 years and older who tested negative for SARS-CoV-2 and were asymptomatic at enrollment but had been exposed to a household member with symptomatic COVID-19.¹ In the primary analysis population (n=2,041), 2.9% of participants who received ensitrelvir developed symptomatic COVID 19 by day 10, compared with 9% of those who were given placebo (risk ratio, 0.33; p < 0.0001). Ensitrelvir was administered orally at a dose of 375 mg on day 1, followed by 125 mg once daily on days 2–5; treatment was initiated within three days of symptom onset in the infected household contact. If approved, ensitrelvir will be the first medication demonstrated to prevent COVID-19 following household exposure to SARS-CoV-2.

For more information, see the ensitrelvir Deep Dive in the January 2026 edition of Prime’s Quarterly Drug Pipeline.

June 18, 2026: tebipenem HBr
GlaxoSmithKline has resubmitted a New Drug Application (NDA) for tebipenem HBr for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. This is the second review of the product following a Complete Response Letter (CRL) issued by the FDA in 2022 requesting an additional clinical trial. The double-blind, Phase 3 PIVOT-PO trial demonstrated that oral tebipenem HBr, administered as 600 mg every six hours, was non-inferior to intravenous (IV) imipenem-cilastatin (500 mg every six hours) in hospitalized patients with cUTI.² Non-inferiority was established based on an overall response at the test-of-cure visit―a composite endpoint of clinical cure plus microbiological eradication―which was achieved in 58.5% of patients treated with tebipenem HBr compared to 60.2% of those who received imipenem-cilastatin. Tebipenem HBr has received Fast Track and Qualified Infectious Drug Product designations from the FDA. If approved, it will be the first oral carbapenem for cUTI.  
June 20, 2026: cytisinicline

Cytisinicline is a nicotinic acetylcholine receptor partial agonist designed to reduce the severity of nicotine craving. The Phase 3, double-blind, placebo-controlled ORCA-2 (n=810) and ORCA-3 (n=792) trials evaluated cytisinicline in addition to behavioral support for smoking cessation in adults who smoked cigarettes daily (≥ 10 cigarettes/day) and were motivated to quit.³˒⁴ In both trials, cytisinicline administered orally three times daily achieved significantly higher rates of smoking abstinence, the primary endpoint, compared with placebo across both 6 week and 12 week treatment durations (p<0.001 for all comparisons). In the ORCA-2 trial, smoking abstinence was reported in 25.3% of participants who were in the cytisinicline group versus 4.4% in the placebo group during the 6-week regimen and 32.6% and 7%, respectively, with the 12-week regimen. The ORCA-3 trial reported smoking abstinence rates of 14.8% versus 6%, respectively, with the 6-week course and 30.3% versus 9.4%, respectively, with the 12-week course. If approved, cytisinicline would compete with the nicotinic receptor partial agonist varenicline (Chantix) for smoking cessation. Cytisinicline may offer a flexible treatment duration and potentially improved gastrointestinal tolerability compared with Chantix. Notably, in 2025, the Institute for Clinical and Economic Review (ICER) revised its evidence report assessing cytisinicline and varenicline for smoking cessation.

For more information, see the cytisinicline Deep Dive in the January 2026 edition of Prime’s Quarterly Drug Pipeline.

June 27, 2026: sirolimus + pegadricase (NASP)
Swedish Orphan Biovitrum (SOBI) is awaiting an FDA decision for nanoencapsulated sirolimus plus pegadricase (NASP) for the treatment of uncontrolled gout. The FDA has granted NASP Fast Track designation. NASP is administered every four weeks as a two-component IV infusion consisting of nanoencapsulated sirolimus (NAS), followed by pegadricase. Pegadricase is a yeast uricase enzyme that reduces serum uric acid levels and NAS mitigates anti-drug antibodies (ADAs) to pegadricase, which can limit treatment durability. The Phase 3, placebo-controlled DISSOLVE I (U.S. study; n=115) and DISSOLVE II (global study; n=158) replicate trials evaluated high and low doses of NASP.⁵ Treatment response was defined as achievement of serum uric acid level below 6 mg/dL for at least 80% of time during month 6 of therapy. In both trials, responder rates were significantly greater with both the high and low doses compared with placebo (DISSOLVE I: 56%, 48% versus 4%, respectively [p<0.0001 for each comparison]; DISSOLVE II: 47%, 41% versus 12%, respectively [p≤0.0002]). If approved, NASP will provide an alternative to pegloticase (Krystexxa) for patients with uncontrolled gout, with once-monthly dosing compared with Krystexxa’s every-two-week dosing schedule.
June 29, 2026: oxylanthanum carbonate
Unicycive resubmitted its 505(b)(2) NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). The 505(b)(2) regulatory pathway permits data from previously approved active ingredients. This is the second review of OLC, following the CRL issued by the FDA in June 2025 related to deficiencies found at a manufacturing facility that were unrelated to OLC. OLC contains lanthanum and utilizes Unicycive’s proprietary nanoparticle formulation, which provides the same binding capacity as lanthanum carbonate (Fosrenol) in a smaller tablet. Unlike Fosrenol’s large tablets, which must be chewed, OLC tablets are designed to be easily swallowed. A Phase 1, open-label, two-way crossover study demonstrated bioequivalence between OLC and lanthanum carbonate in healthy individuals.⁶ In addition, a Phase 2 multidose study (NCT06218290) showed that, OLC reduced pill burden by 50% compared with pre-trial phosphate binders (three tablets versus six tablets, respectively), improved adherence to therapy (70% versus 58%) and increased patient satisfaction (98% versus 38%) in patients with CKD.⁷ 
June 30, 2026: veligrotug

Veligrotug is an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody developed by Viridian and submitted to the FDA for the treatment of thyroid eye disease (TED). Veligrotug was evaluated in the double-blind, placebo-controlled, Phase 3 THRIVE (n=113) and THRIVE-2 (n=188) trials. Both studies assessed reduction in proptosis (abnormal bulging of the eye) as the primary endpoint.  At week 15, both trials demonstrated statistically significant improvements in responder rates with veligrotug compared to placebo (THRIVE: 70% versus 5%; THRIVE-2: 56% versus 8%) and proptosis mean change from baseline (THRIVE: -2.89 mm versus -0.48 mm; THRIVE-2: -2.34 mm versus -0.46 mm) (p<0.0001 for all comparisons). If approved, veligrotug will be the second IGF-1R inhibitor approved by the FDA for the treatment of TED and will compete with the IGF-1R inhibitor teprotumumab-trbw (Tepezza). Safety profiles appear similar between the two agents; however, veligrotug may offer a more convenient dosing schedule, requiring five 30-minute infusions compared to Tepezza’s eight 60- to 90- minute infusions. Both therapies are given every three weeks.

For more information, see the veligrotug Deep Dive in the April 2026 edition of Prime’s Quarterly Drug Pipeline.