In the Pipeline: Clinical Trials

PHASE 1 TRIALS

• BMS-986326, an IL-2 fusion protein, is undergoing a Phase 1b study in adults with moderate-to-severe AD. BMS-986326 was among five drugs in-licensed by an independent company launched by Bristol Myers Squibb and Bain Capital.
• KT-621, a once-daily, oral degrader of STAT6 from Kymera Therapeutics, Inc., is being evaluated in adults with moderate-to-severe AD in a multicenter, open-label, single-arm Phase 1 study. The study started in April 2025 and is estimated for completion in December 2025.
• IBI3002, a bispecific antibody targeting IL-4Rα and thymic stromal lymphopoietin (TSLP) from Innovent Biologics, Inc., is the subject of a study of multiple doses in participants with moderate-to-severe AD. The study started in July 2025 and is estimated for completion in May 2026.
• LPX-TI641, an orally bioavailable small molecule T cell immunoglobulin and mucin domain-containing protein (TIM) 3/4 receptor agonist, is being evaluated in a multiple dose Phase 1b study in participants with AD or psoriasis. The study, sponsored by LAPIX Therapeutics Inc., started in June 2025 and is estimated for completion in the first half of 2026.
• TRB-061, a TNFR2-selective agonist developed by TRexx Bio, Inc., is the subject of a randomized, double-blind, placebo-controlled Phase 1a study of single ascending doses administered subcutaneously in healthy adults. The study started in May 2025 and is estimated for primary completion in July 2026.
• GB-7624, an IL-13 inhibitor, is being evaluated in a randomized, double-blinded, placebo-controlled Phase 1 study sponsored by Generate Biomedicines. The study began in March 2025 and is estimated for completion in June 2026.
• ATTO-1310, a half-life extended anti-IL-31 ATTOBODY developed by Attovia Therapeutics, is being evaluated in a single ascending dose and multiple ascending dose Phase 1 study in healthy adults, patients with AD, and patients with chronic pruritus. The study started in January 2025 and is estimated for completion in May 2026. 
• BBT001, a half-life extended bispecific antibody from Bambusa Therapeutics, Inc., is the subject of a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 study in healthy volunteers and adults with moderate-to-severe AD. The study started in February 2025 and is estimated for primary completion in August 2026.

PHASE 2 TRIALS

• Lunsekimig, a Nanobody VHH® from Sanofi that combines targeting of IL-13 and thymic stromal lymphopoietin (TSLP), is the subject of a Phase 2b study in adults with moderate-to-severe AD. The study started in February 2025 and is estimated for completion in mid-2026.
• ZL-82 tablets, highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3, are being evaluated in a Phase 2 trial for adults with moderate-to-severe AD. The study, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd., was expected to start in Q4 of 2025 and primary completion expected by the end of 2026.
• TRIV-509 is the subject of a Phase 2a study initiated in August 2025 and estimated for primary completion in October 2026 in adults with moderate-to-severe atopic dermatitis. The drug, developed by Triveni Bio, Inc., inhibits kallikreins 5 and 7.
• RSS0309 ointment is the subject of a Phase 2 clinical study in adults with mild-to-moderate AD. Sponsored by Reistone Biopharma Company Limited, the study started in September 2025 and is estimated for completion in the first half of 2026.
• EVO756 is the subject of a dose-ranging Phase 2b study in adults with moderate-to-severe AD. The study, sponsored by Evommune, Inc., started in August 2025 and is estimated for completion in July 2026.
• Roflumilast cream 0.05% is being evaluated for safety and tolerability in infants 3 months and younger with AD when applied once daily for 4 weeks in an open-label, 4-week Phase 2 study that began in June 2025 and is estimated for completion in June 2026.
• BFB759 is being evaluated in a dose-ranging Phase 2 study in adults with moderate-to-severe AD. The drug, developed by Bluefin Biomedicine, Inc., is a human monoclonal antibody that inhibits multiple pro-inflammatory cytokines. The study started in July 2025 and is estimated for completion in early 2027.
• APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, is the subject of a long-term extension Phase 2b study in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study. Sponsored by Apogee Therapeutics, Inc., the study started in May 2025 and is estimated for completion in December 2029.
• MG-K10, a humanized anti-IL-4Rα monoclonal antibody developed by Shanghai Mabgeek Biotech.Co.Ltd, is the subject of a Phase 2 study for adult patients with moderate-to-severe AD. The study was expected to start in late 2025 and end in the second half of 2027.
• VC005, a second-generation selective oral JAK1 inhibitor from Jiangsu Vcare Pharmaceutical Technology Co., Ltd, is being studied for treatment of moderate-to-severe AD in a Phase 2 clinical study that began in April 2025 and is estimated for completion in December 2025.
• Afimkibart, a fully human IgG1 monoclonal antibody that targets and blocks tumor necrosis factor-like ligand 1A (TL1A), is the subject of a Phase 2 study in patients with moderate-to-severe AD. Sponsored by Hoffmann-La Roche, the study started in April 2025 and is estimated for completion in the second half of 2026.
• IMG-007, a humanized IgG1 monoclonal antibody developed by Inmagene LLC, is the subject of a Phase 2b study of various dose regimens in adults with moderate-to-severe AD up to 52 weeks. The study started in June 2025 and is estimated for primary completion in November 2026.
• Busakitug, a humanized anti-TSLP monoclonal antibody that specifically binds to human TSLP, is the subject of a Phase 2 trial for patients with moderate-to-severe AD. Initiated in May 2025, it is estimated for completion in the second half of 2026. It is developed by Aclaris Therapeutics, Inc.
• Zabalafin hydrogel is the subhect of a Phase 2b study for mild-to-moderate AD. Developed by Alphyn Biologics, the drug is said to directly treat all the problems of AD: the bacterial cause, pruritus, and the immuno-inflammatory cause. The study started in March 2025 and was estimated for completion in the fourth quarter of 2025.
• JNJ-95475939, a bispecific antibody from Janssen Research & Development, LLC, is being evaluated for treatment of moderate-to-severe AD in a dose-ranging Phase 2 study that started in February 2025 and is estimated for completion in the third quarter of 2026.
• LNK01004 ointment, a soft pan-JAK inhibitor, is the subject of a Phase 2 study in adults with AD. The study, sponsored by Lynk Pharmaceuticals Co., Ltd, started in March 2025 and is estimated for completion later in the year.
• CM512, a bispecific antibody targeting TSLP and IL-13, is the subject of a Phase 2 study in adults with moderate-to-severe AD. The study, sponsored by Keymed Biosciences Co., Ltd, started in June 2025 and is estimated for completion in the second half of 2026.
• XKH001, a recombinant humanized IgG1 monoclonal antibody against IL-25, was scheduled to be evaluated in a Phase 2 clinical study in adult patients with moderate-to-severe AD starting in the second half of 2025, sponsored by Zhejiang Kanova Biopharmaceutical Co., Ltd.
• IN-115314 ointment, a JAK1 inhibitor, is expected to be evaluated for mild-to-moderate AD in adults in a study to start later this year and end in September 2026. The study is sponsored by HK inno.N Corporation.

PHASE 3 TRIALS

• OPA-15406 foam will be studied in children and infants with AD in a parallel-group comparison trial and an open-label, uncontrolled trial in infants under 2 and children, both of which were scheduled to start in September 2025 and end in February 2027.
• QY201 tablets are being evaluated for adults with moderate-to-severe AD in a Phase 3 clinical study that started in March 2025 and is estimated for completion by mid-2027. The tablets, developed by E-nitiate Biopharma, simultaneously inhibit JAK and TYK2 pathway signaling.
• SIM0278, an IL-2 mutant fusion protein, will be evaluated in adults with moderate-to-severe AD in a Phase 3 study expected to start later this year and estimated for primary completion in August 2026. 
• Stapokibart, a humanized monoclonal antibody that targets IL-4Ra, is being evaluated in children with AD in a Phase 3 study expected to start later this year and end in the first half of 2027. The study is sponsored by Keymed Biosciences Co., Ltd.