Dupixent dupilumab APPROVED
Drug Profile
ModalityMonoclonal antibody
RouteSC
Therapy AreaImmunology
Launch2017-03-28
Peak Sales Est$25000M
Formulations[{"id":"dupixent-sc","doses":"200mg or 300mg Q2W (weight/indication-based); loading dose 600mg","rou
Companies
REGN (CO_DEVELOPER)50%
SNY (CO_DEVELOPER)50%
Mechanism: IL-4Rα inhibitor (monoclonal antibody)
Expert: Fully human IgG4 monoclonal antibody targeting IL-4 receptor alpha subunit. Inhibits both IL-4 and IL-13 signaling (shared receptor component). Blocks type 2 inflammation across multiple tissues: skin (AD), airways (asthma), sinuses (CRSwNP), esophagus (EoE).
Everyday: Blocks the IL-4 receptor alpha on immune cells — the master switch for type 2 inflammation. Without this signal, the entire allergic/inflammatory cascade shuts down. Like cutting the power supply to a factory that makes inflammation.
Targets: ["IL-4Rα","IL-4R"]
Revenue History
PeriodRevenue ($M)
Q1 2024$3,077M
Q2 2024$3,556M
Q3 2024$3,817M
Q4 2024$3,698M
2024$14,148M
Q1 2025$3,666M
Q2 2025$4,345M
Q3 2025$4,857M
Q4 2025$4,940M
2025$17,807M
Programs (10)
IndicationStageKey StudyRegional Status
Atopic dermatitisAPPROVEDLIBERTY AD SOLO 1/2, CHRONOS[{"stage":"APPROVED","region":"US","approval_date":"2017-03-28"},{"stage":"APPRO
Asthma (≥12y)APPROVEDLIBERTY ASTHMA QUEST[{"stage":"APPROVED","region":"US","approval_date":"2018-10-19"}]
Asthma (6-11y)APPROVEDLIBERTY ASTHMA VOYAGE[{"stage":"APPROVED","region":"US","approval_date":"2021-10-01"}]
CRSwNPAPPROVEDLIBERTY NP SINUS-24/52[{"stage":"APPROVED","region":"US","approval_date":"2019-06-26"}]
EoEAPPROVEDLIBERTY EoE TREET[{"stage":"APPROVED","region":"US","approval_date":"2022-05-20"}]
Prurigo nodularisAPPROVEDLIBERTY-PN PRIME/PRIME2[{"stage":"APPROVED","region":"US","approval_date":"2022-09-28"}]
Pediatric asthma (<6y)PHASE3LIBERTY ASTHMA VOYAGE <6[]
CSUPHASE3LIBERTY-CSU CUPID[]
CPUOPHASE3LIBERTY-CPUO[]
COPD (type 2/inflammatory)APPROVEDBOREAS / NOTUS[{"stage":"APPROVED","region":"US","approval_date":"2024-09-27"}]
Clinical Studies (7)
LIBERTY AD SOLO 1 PHASE3
COMPLETED · n=671
Primary EP: [{"id":"solo1-iga01","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"notes":"38% vs 10% placebo","value":38,"arm_id":"dupixent-300-q2w-solo1","p_value":"<0.001","arm_name":"Dupilu
Efficacy: SOLO 1 met primary endpoint: 38% IGA 0/1 with dupilumab 300mg Q2W vs 10% placebo (p<0.001). EASI-75: 51% vs 15% (p<0.001). Rapid and clinically meaningful improvement in AD.
Safety: SOLO 1 (n=671): Well-tolerated. Most common AEs: nasopharyngitis 11% vs 13%, injection site reactions 10% vs 5%, conjunctivitis 10% vs 2%, headache 6% vs 7%. Conjunctivitis is a known class effect of
NCT02277743
LIBERTY ASTHMA QUEST PHASE3
COMPLETED · n=1902
Primary EP: [{"id":"quest-exacerbations","name":"Annualized severe asthma exacerbation rate","type":"PRIMARY","unit":"events/year","results":[{"notes":"47.7% reduction vs placebo","value":0.46,"arm_id":"dupixent-
Efficacy: QUEST met primary endpoint: 47.7% reduction in severe exacerbation rate with Dupilumab 300mg Q2W vs placebo (RR 0.52, p<0.001). FEV1 improved +0.13L vs placebo at Week 12 (p<0.001). Benefit seen across eosinophil subgroups.
Safety: QUEST (n=1902, 52 weeks): Injection site reactions 18% vs 6%. Transient eosinophilia 5% vs 1% (resolved on treatment). No meaningful safety differences otherwise.
NCT02414854
BOREAS PHASE3
COMPLETED · n=939
Primary EP: [{"id":"boreas-exacerbations","name":"Annualized moderate-to-severe COPD exacerbation rate","type":"PRIMARY","unit":"events/year","results":[{"notes":"30% reduction vs placebo","value":0.78,"arm_id":"
Efficacy: BOREAS met primary endpoint: 30% reduction in moderate-to-severe COPD exacerbations (RR 0.70, 95% CI 0.58-0.86, p=0.0005). Pre-BD FEV1: +160 mL vs placebo at Week 12 (p<0.001). First biologic to show exacerbation AND FEV1 benefit in COPD.
Safety: BOREAS (n=939, 52 weeks): Well-tolerated in COPD. No new safety signals vs asthma/AD experience. Most common: viral infection 14% vs 12%, headache 8% vs 7%.
NCT03930732
LIBERTY AD SOLO 2 PHASE3
COMPLETED · n=708
Primary EP: [{"id":"solo2-iga01","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"notes":"36% vs 8% placebo","value":36,"arm_id":"dupixent-300-q2w-solo2","p_value":"<0.001","arm_name":"Dupilum
Efficacy: SOLO 2 confirmed SOLO 1: 36% IGA 0/1 with dupilumab Q2W vs 8% placebo (p<0.001). EASI-75: 44% vs 12% (p<0.001). Together with SOLO 1, supported FDA approval for moderate-to-severe AD.
Safety: SOLO 2 (n=708, 16 weeks): Consistent with SOLO 1. Injection site reactions 12% vs 6%, conjunctivitis 9% vs 2%. Well-tolerated.
NCT02277769
LIBERTY EoE TREET PHASE3
COMPLETED · n=321
Primary EP: [{"id":"treet-histo","name":"Histological remission at Week 24 (peak eos ≤6/hpf)","type":"CO_PRIMARY","unit":"%","results":[{"notes":"60% achieved histological remission vs 5% placebo","value":60,"arm
Efficacy: TREET met co-primary endpoints: 60% histological remission (≤6 eos/hpf) vs 5% placebo (p<0.001). DSQ improvement: -21.9 vs -9.6 (p<0.001). First FDA-approved treatment for EoE (May 2022).
Safety: TREET (n=321, 24 weeks): ISR 10% vs 5%, nasopharyngitis 9% vs 9%. Consistent with known Dupixent safety profile. No new signals in EoE population.
NCT03633617
LIBERTY SINUS-24 PHASE3
COMPLETED · n=276
Primary EP: [{"id":"sinus24-nps","name":"Change in nasal polyp score (NPS) at Week 24","type":"CO_PRIMARY","unit":"points","results":[{"notes":"LS mean difference vs placebo: -1.89 (p<0.0001)","value":-1.89,"arm_
Efficacy: SINUS-24 met co-primary endpoints: NPS -1.89 (p<0.0001) and LMS -8.82 (p<0.0001) vs placebo. SNOT-22: -21.12 (>2x MCID). First biologic for CRSwNP.
Safety: SINUS-24 (n=276, 24 weeks): Well-tolerated. Nasopharyngitis 12% vs 14%, ISR 6% vs 3%.
NCT02912468
LIBERTY-PN PRIME PHASE3
COMPLETED · n=151
Primary EP: [{"id":"prime-pp-nrs","name":"Pruritus improvement (WI-NRS ≥4 point reduction) at Week 24","type":"PRIMARY","unit":"%","results":[{"notes":"60% vs 18% placebo","value":60,"arm_id":"dupixent-pn-prime",
Efficacy: PRIME: 60% itch reduction vs 18% placebo (p<0.001). IGA 0/1: 48% vs 18%. First FDA-approved treatment for PN.
Safety: PRIME (n=151): Excellent tolerability. Nasopharyngitis 8% vs 9%.
NCT04183335
Upcoming Catalysts (1)
Dupixent - CSU - Ph3 Topline (LIBERTY-CSU CUPID) 2026
Notes
BLOCKBUSTER — largest drug in immunology. +26% YoY. 50/50 co-development with Sanofi. SNY books global net sales; REGN receives collaboration revenue (~$5.9B in FY2025). 7 approved indications spanning AD, asthma, CRSwNP, EoE, COPD, PN. Multiple expansion programs (CSU, CPUO, pediatric asthma <6). First-in-class IL-4Rα blocker with broad type 2 inflammation platform.
Safety Profile
{"keyRisks":[{"category":"Hypersensitivity","description":"Anaphylaxis and angioedema reported. Discontinue if severe reaction occurs.","incidenceRate":"<1%"},{"category":"Conjunctivitis/keratitis","description":"New or worsening eye disorders. 10% in AD trials vs 2% placebo. Monitor and treat.","incidenceRate":"1-10%"},{"category":"Eosinophilic conditions","description":"Hypereosinophilia, eosinophilic pneumonia reported. Do not abruptly stop OCS in asthma/COPD.","incidenceRate":"<1%"},{"category":"Arthralgia","description":"Joint pain reported, sometimes severe. May lead to discontinuation.","incidenceRate":"1-3%"}],"monitoring":["Eye symptoms (conjunctivitis, keratitis)","Eosinophil counts","Parasitic infections (treat before starting)"],"classWarnings":["Do not abruptly reduce corticosteroids when starting dupilumab"],"hasBoxedWarning":false}
Data from Supabase · Updated 2026-03-24