Three Innovative Therapies Await FDA Approval in June 2026

▲6Month United StatesFDAPotential New Drug Approvals (Dot(Click to view full-size image)

Active Ingredient:Tebipenem HBr

Indications:Complicated Urinary Tract Infection

Company Name:GSK、Spero Therapeutics

Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.In February 2026, GSK announced that the U.S. FDA had set the PDUFA date for the New Drug Application (NDA) for tebipenem HBr as June 18, 2026.

This NDA is supported by the results of the Phase 3 PIVOT-PO trial. The trial was terminated early in May 2025 due to efficacy meeting the prespecified criteria. The study results demonstrated that tebipenem HBr met the primary endpoint, showing non-inferiority compared to the control intravenous regimen. In hospitalized patients with complicated urinary tract infections (including pyelonephritis),Oral tebipenem HBr demonstrated comparable efficacy to the control intravenous regimen in terms of overall response rates for clinical cure and bacterial eradication, which were 58.5% (261/446) and 60.2% (291/483), respectively, with an adjusted treatment difference of -1.3% (95% CI: -7.5%, 4.8%).In terms of safety, tebipenem HBr was generally consistent with the comparator intravenous regimen and other carbapenem antibiotics. The most common adverse events (≥3%) were diarrhea and headache, all of which were mild to moderate in severity and non-serious.

Active Ingredient:Nanoencapsulated sirolimus plus pegadricase（NASP）

Indications:Uncontrolled Gout

Company Name:Sobi

Nanoencapsulated sirolimus plus pegadricase is an innovative infusion therapy administered once every four weeks, comprising nanoencapsulated sirolimus with targeted immunomodulatory effects and the pegylated uricase pegadricase.. The FDA has set the PDUFA date for this therapy as June 27, 2026.

NASP’s Biologics License Application (BLA) includes results from the Phase 3 DISSOLVE I and II placebo-controlled, randomized clinical trials, which evaluated the safety and efficacy of two different dose levels of NASP in adult patients with uncontrolled gout.Both studies met their primary endpoint, defined as achieving and maintaining serum uric acid (sUA) levels below 6 mg/dL for at least 80% of the time during Month 6. In DISSOLVE I and II, the combined response rates for the high-dose and low-dose NASP groups were 51% and 43%, respectively.

In addition to achieving the primary endpoint, NASP treatment resulted in a rapid and sustained reduction in serum uric acid (sUA) levels following the initial dose and throughout the study period. The study also observed improvements in key clinical symptoms, including resolution of tophi, reduced frequency of gout flares over time, and improved patient-reported quality of life. In clinical trials, NASP was generally well tolerated at both dose levels.

Active Ingredients:Veligrotug

Indications:Thyroid Eye Disease (TED)

Company Name:Viridian Therapeutics

Veligrotug is an intravenously administered antibody targeting the insulin-like growth factor-1 receptor (IGF-1R).Viridian Therapeutics announced in December 2025 that the FDA had accepted the Biologics License Application (BLA) for veligrotug and granted it Priority Review, with a PDUFA date set for June 30, 2026.

The BLA is primarily based on data from two pivotal Phase 3 clinical trials, THRIVE and THRIVE-2, which validated the efficacy and safety of veligrotug in patients with active-phase and chronic-phase Thyroid Eye Disease (TED), respectively. The results demonstrated that both studies met all primary and secondary endpoints. The drug exhibited favorable overall tolerability and a rapid onset of action, particularly showing outstanding performance in improving diplopia-related metrics. Previously announced results from the THRIVE trial showed that,At Week 15, the proptosis response rate among patients treated with veligrotug was 70%, with a placebo-adjusted proptosis response rate of 64% (p<0.0001). Notably, 53% of patients experienced significant improvement in proptosis symptoms within 3 weeks, having received only a single treatment at that time.

Beyond innovative therapies that may receive regulatory decisions in June, an analysis of the structure of new drugs approved by the FDA in 2026 reveals that peptide therapies are also emerging as a noteworthy area of innovation.

Integrated Platform Accelerates Peptide Therapy Development

As of 2026, the U.S. FDA’s CDER has approved 19 innovative drugs, including three peptide therapies., namely Icotyde (icotrokinra) jointly developed by Johnson & Johnson and Protagonist Therapeutics, Yuviwel (navepegritide) developed by Ascendis Pharma, and Awiqli (insulin icodec) from Novo Nordisk. Currently,The number of peptide therapies approved in 2026 has already matched the total number of innovative peptide therapies approved by the FDA throughout 2024 and 2025.Furthermore, rusfertide, jointly developed by Takeda and Protagonist Therapeutics; Novo Nordisk’s CagriSema; and Merck & Co.’s (MSD) macrocyclic peptide PCSK9 inhibitor, enlicitide decanoate, are all poised for potential FDA approval in 2026, underscoring the strong momentum of peptide therapies as an innovative treatment modality.

WuXi Biology, the biology platform of WuXi AppTec, has established an integrated solution covering early discovery and optimization of peptides, providing partners with systematic support from lead compound discovery to candidate molecule advancement. The platform integrates complementary discovery technologies, such as peptide DNA-encoded libraries (DEL) and display technologies (phage display and mRNA display), to explore molecular diversity spaces exceeding trillions within a single project, thereby enabling efficient discovery of peptide lead compounds. Leveraging an off-the-shelf peptide library of over 300 billion compounds and highly customizable design capabilities, the platform supports the construction of linear and cyclic peptides and allows for the incorporation of hundreds of non-natural amino acids along with various cyclization strategies to enhance molecular stability and drugability. During the “Hit-to-Lead” optimization phase, WuXi Biology combines high-throughput decoding, computational modeling, and machine learning methods, while systematically characterizing binding, permeability, stability, and function through biophysical, biochemical, structural biology, cellular, and DMPK assessment systems. This accelerates structure-activity relationship (SAR) iteration and peptide performance optimization. By deeply integrating discovery technologies, functional biology, and downstream development capabilities, WuXi Biology helps clients reduce early-stage R&D risks and accelerate the translation of peptide innovations into clinical candidates.

Amid the rapid development of peptide therapeutics, their susceptibility to proteolytic degradation, limited in vivo stability, and significant inter-tissue metabolic variations make systematic DMPK studies a critical link in driving the successful translation of candidate molecules. Focusing on the structural and in vivo behavioral characteristics of peptide molecules, WuXi AppTec’s DMPK team has established an integrated research system covering in vitro property evaluation, metabolic stability studies, and in vivo pharmacokinetic analysis, providing continuous data support from drug discovery through the IND filing stage. Leveraging a multi-tissue and multi-matrix research platform, the team conducts stability and metabolism studies in various systems, including whole blood, plasma, lysosomes, liver and kidney S9 fractions, tissue homogenates, and simulated gastrointestinal fluids. This approach systematically evaluates the degradation pathways and clearance mechanisms of peptides in different physiological environments, thereby elucidating the relationship between structural modifications and exposure levels. Furthermore, by integrating studies using hepatocytes, microsomes, and cross-species models, key parameters such as half-life and intrinsic clearance can be quantitatively obtained, providing a basis for species selection and dose prediction.

Leveraging systematic research experience on the metabolic differences of peptides in the gastrointestinal tract, liver, kidneys, and circulatory system, WuXi AppTec’s DMPK team can mechanistically elucidate the ADME behavior of peptide drugs. By integrating studies on protein binding, permeability, and metabolite identification, the team supports structure optimization and delivery strategy design. This platform has supported over 100 peptide R&D projects globally, covering the entire workflow from screening and optimization through candidate selection to IND-enabling studies, thereby providing continuous empowerment from early mechanistic understanding to clinical translation readiness. Through interdisciplinary collaboration and standardized research processes, WuXi AppTec’s DMPK helps clients reduce uncertainties in peptide drug development, accelerate the advancement of candidate molecules into clinical stages, and serve as a critical support platform bridging innovative molecular design with developable therapeutics.

References:

[1] Spero Therapeutics Announces First Quarter 2026 Operating Results and Provides Business Update. Retrieved May 19, 2026, from https://www.globenewswire.com/news-release/2026/05/13/3294434/0/en/spero-therapeutics-announces-first-quarter-2026-operating-results-and-provides-business-update.html

[2] FDA Accepts Biologics License Application for Sobi's NASP for Patients with Uncontrolled Gout. Retrieved May 19, 2026, from https://www.prnewswire.com/news-releases/fda-accepts-biologics-license-application-for-sobis-nasp-for-patients-with-uncontrolled-gout-302552102.html

[3] Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease. Retrieved May 19, 2026, from https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Announces-BLA-Acceptance-and-Priority-Review-for-Veligrotug-for-the-Treatment-of-Thyroid-Eye-Disease/default.aspx

[4] FDA Accepts Shionogi’s Ensitrelvir NDA as the First Oral Therapy for the Prevention of COVID-19 Following Exposure. Retrieved May 20, 2026, from https://www.shionogi.com/us/en/news/2025/09/fda-accepts-shionogis-ensitrelvir-nda-as-the-first-oral-therapy-for-the-prevention-of-covid-19-following-exposure.html

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