Delving into the Latest Updates on Lebrikizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

ANTI-IL-13, Lebrikizumab (genetical recombination) (JAN), Lebrikizumab (USAN/INN)

+ [15]

Target

IL-13

Action

inhibitors

Mechanism

IL-13 inhibitors(Interleukin-13 inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [3]

Active Indication

Dermatitis, AtopicNummular eczemaNasal Polyps+ [7]

Inactive Indication

airway diseaseAirway ObstructionAllergic asthma+ [5]

Originator Organization

Active Organization

+ [6]

Inactive Organization

Hoffmann-La Roche, Inc.Tanox, Inc.

License Organization

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (16 Nov 2023),

Dermatitis, Atopic

RegulationFast Track (United States)

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Structure/Sequence

Sequence Code 142719L

Source: *****

Sequence Code 9082543H

Source: *****

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)

Start Date24 Apr 2026

Sponsor / Collaborator

Almirall SA

CTIS2024-519811-32-00

/ Not yet recruitingPhase 4

An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Start Date01 Apr 2026

Sponsor / Collaborator-

NCT07352566

/ Not yet recruitingPhase 4IIT

Utilization of a Cutaneous Therapy In Situ Microdevice

This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of California, San Francisco

100 Clinical Results associated with Lebrikizumab

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100 Translational Medicine associated with Lebrikizumab

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100 Patents (Medical) associated with Lebrikizumab

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240

Literatures (Medical) associated with Lebrikizumab

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases

Review

Author: Yang, Xuefan ; Ruan, Dandan ; Li, Sitong ; Chen, Xiang ; Lin, Jiacheng ; Qiu, Xinlan ; Li, Jiaqi ; Ju, Qiang ; Mo, Xiaohui

PURPOSE:

Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.

MATERIALS AND METHODS:

We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.

RESULTS:

A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.

CONCLUSIONS:

DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.

02 Mar 2026·Dermatitis

Decision-Making Factors for Systemic Therapies in Atopic Dermatitis: A Clinical Review.

Review

Author: Mehta, Apoorva ; Guttman-Yassky, Emma ; O'Hagan, Ross ; Lamb, Angela J ; Levine, Jasmine

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that significantly impairs quality of life. In recent years, treatment has advanced from broad immunosuppressants to targeted biologics and small-molecule therapies that modulate type 2 inflammation and itch signaling. Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are now FDA-approved biologics with demonstrated efficacy and favorable long-term safety, while oral Janus kinase inhibitors (JAKis) such as abrocitinib, upadacitinib, and baricitinib often provide rapid disease control but carry black-box warnings. Comparative trials highlight faster itch relief with JAKis but durable disease control and safety advantages with biologics. The expanding treatment landscape necessitates individualized therapy selection. Key clinical considerations include patient age, pregnancy status, infection, malignancy, or thromboembolic risk, comorbid conditions, and history of adverse effects. Equally important are patient-centered preferences such as dosing frequency, route of administration, storage logistics, and willingness to self-inject. Access and affordability also influence care, with many manufacturers offering copay support and patient assistance programs. Future directions emphasize head-to-head comparative studies, biomarker development for precision treatment, and equitable access to advanced therapies. This narrative review synthesizes current evidence on biologics and JAKis in AD, outlining efficacy, safety, and practical decision-making factors to guide dermatologists in aligning therapies with both clinical context and patient priorities.

01 Mar 2026·JOURNAL OF DERMATOLOGY

Clinical Outcomes of Tralokinumab and Lebrikizumab in Japanese Atopic Dermatitis Patients With Persistent Head and Neck Dermatitis After Long‐Term Treatment With Dupilumab: A Single‐Center Retrospective Study

Letter

Author: Chijiwa, Chika ; Okada, Yoshiki ; Tada, Yayoi ; Suzuki, Shoya ; Hiura, Azusa ; Kamata, Masahiro ; Tomura, Yayoi ; Hayashi, Kotaro ; Watanabe, Ayu ; Tanaka, Takamitsu

178

News (Medical) associated with Lebrikizumab

23 Mar 2026
·www.fiercebiotech.com

Apogee eczema data drive hype to new peak as threat to Lilly and Sanofi becomes clear

Analysts said deepening response rates across all key endpoints were the most surprising and impressive outcomes of Apogee Therapeutics\' phase 2 eczema data .\n Apogee Therapeutics has published phase 2 eczema data that suggest its anti-IL-13 antibody is a threat to Eli Lilly, Regeneron and Sanofi, prompting analysts to double their peak sales forecast to $5.2 billion.The data come from the maintenance stage of a phase 2 trial. At the end of the induction period, Apogee re-randomized all patients in the zumilokibart cohort to receive the anti-IL-13 antibody every three or six months. After 52 weeks, 85% of patients randomized to the six-month regimen maintained the 75% improvement on the EASI symptom scale they achieved during the induction stage.At 75%, the EASI maintenance rate was lower on the three-month regimen. But Guggenheim Securities analysts said in a note to investors that both regimens performed at least as well as Eli Lilly’s Ebglyss and Sanofi and Regeneron’s Dupixent, based on cross-trial comparisons. The analysts quoted EASI-75 maintenance rates of 82% and lower for Ebglyss and 72% for Dupixent. Data on zumilokibart’s maintenance of vIGA 0/1 outcomes, which indicate clear or almost clear skin, also compared favorably to results for Ebglyss and Dupixent. Apogee reported vIGA 0/1 maintenance rates of 86% and 78%, respectively, for the three- and six-month regimens. The analysts compared the results to a rate of 54% for Dupixent and up to 77% for Ebglyss. Ebglyss was given every two or four weeks in the trial data referenced by the analysts, while Dupixent was administered every one or two weeks. While cross-trial comparisons can be unreliable, the data suggest zumilokibart can achieve at least comparable maintenance rates despite being given less frequently. The maintenance data exceeded the Guggenheim analysts’ expectations. While praising the maintenance results, the analysts said the deepening response rates across all key endpoints were the most surprising and impressive aspect of the data. The proportion of patients who had 75%, 90% and 100% improvements on the EASI scale increased between the Week 16 and Week 52 analyses. Apogee also reported deepening responses on vIGA 0/1 and on a measure of itch symptoms. The analysts said the Week 52 results look comparable to data on AbbVie’s blockbuster JAK inhibitor Rinvoq. Monotherapy trials of Dupixent and Ebglyss randomized only responders to maintenance doses, preventing direct comparisons to the vIGA data beyond the maintenance results. The analysts said there was minimal if any deepening of responses after Week 16 in a Dupixent combination trial.Encouraged by the data, the analysts said they are increasingly convinced that zumilokibart will become the first-line treatment for most eczema patients. The prediction reflects the drug candidate’s dosing schedule and its “improving” efficacy profile, the analysts said. In eczema, the analysts expect peak sales of $5.2 billion, up from $2.6 billion before the data drop. The forecast reflects the potential for zumilokibart to claim a larger share of the market than expected. The analysts see chances for Apogee to unlock more sales by moving into indications including eosinophilic esophagitis, where weekly dosing is the current standard of care.Apogee shares rose 20% to $80 when markets opened Monday from a Friday closing price of $66.04.

Clinical ResultPhase 2

23 Mar 2026
·endpoints.news

Apogee’s Phase 2 data show its eczema drug could have the convenience edge over Dupixent, Ebglyss

Apogee Therapeutics said its moderate-to-severe eczema candidate could offer much more convenient dosing over standard treatments based on its latest mid-stage results. Monday’s Phase 2 maintenance data highlighted the efficacy of its anti-IL-13 antibody, called zumilokibart, administered once every three months or every half a year after an induction period. Sanofi and Regeneron’s Dupixent is given every two or four weeks after an initial loading dose, while Eli Lilly’s Ebglyss is given every four weeks after several loading doses. Apogee’s stock $APGE jumped by as much as 16% before the market opened Monday. Its 52-week data showed 75% of initial zumilokibart responders maintained a 75% or more improvement in their Eczema Area and Severity Index (EASI) score with a 360 mg dose once every three months. But that figure was even higher in patients who received zumilokibart once every six months, with 85% maintaining their response. Among people who initially achieved clear or almost clear skin on a separate eczema severity scale called the Validated Investigator Global Assessment (vIGA), 86% of those dosed every three months and 78% of those dosed every six months maintained their response. Monday’s results appear to surpass Apogee’s own benchmarks for success. TD Cowen analysts said earlier this month that the company was hoping to achieve 72% maintenance on the EASI-75 and 53% maintenance on the vIGA. These figures are based on Dupixent’s maintenance data. Last year, Apogee shared topline induction data from the first part of the Phase 2 study. Those results showed almost 70% of patients experienced a minimum 75% improvement in their EASI score at 16 weeks. For the induction regimen, patients were given 720 mg zumilokibart at weeks 0 and 2, followed by 360 mg at weeks 4 and 12. The EASI scale looks at how much a patient’s disease severity has improved from baseline, while the vIGA offers an absolute measure of the clearness of their skin. Apogee said it will present full data from the first part of the Phase 2 trial at the American Academy of Dermatology Annual Meeting in Denver later this week. The biotech also expects to share results from the second part of the study, which focuses on dose optimization, in the second quarter. Apogee plans to start Phase 3 development later this year. It also believes it could launch zumilokibart in 2029. Last week, Jefferies analysts said they expect the drug to reach $1.4 billion in peak sales.

Clinical ResultPhase 2

17 Mar 2026
·firstwordpharma.com

Biopharma bites: A trio of drugs join TrumpRx, BioMarin stops several studies, plus paediatric proof for Lilly's Ebglyss

Drugs from Amgen, GSK join TrumpRxBioMarin stops certain skeletal studies after safety signalLilly's Ebglyss passes paediatric testDrugs from Amgen, GSK join TrumpRxTrumpRx, a direct-to-consumer (DTC) platform run by the US government, welcomed three new products to its site on Monday, according to a post on X from the White House. Amgen is offering its migraine medicine Aimovig (erenumab), as well as Amjevita (adalimumab-atto) — its biosimilar of AbbVie's Humira (adalimumab) — for a monthly cash-pay price of $299 each. GSK's Incruse Ellipta (umeclidinium), an inhaled treatment for chronic obstructive pulmonary disease (COPD), is available for $159.20 per month on TrumpRx for self-pay patients. The three additions to TrumpRx come after the website officially launched in February with price cuts for about 43 medications.Both pharmas, along with seven other drugmakers, agreed in December to sell some of their products on DTC sites as part of a most favoured nation drug pricing agreement with the Trump administration. -Elizabeth EatonBioMarin stops certain skeletal studies after safety signalBioMarin disclosed in a securities filing Monday that, following a safety signal in a pair of investigator-sponsored trials, it has halted its own Phase II studies evaluating Voxzogo (vosoritide) in patients with certain skeletal conditions. The drugmaker said that "several" cases of slipped capital femoral epiphysis (SCFE) occurred in the investigator-sponsored trials. As a result, it will discontinue dosing and enrollment in its studies involving patients with Turner syndrome, SHOX-deficiency and ACAN-deficiency. BioMarin emphasised that SCFE events have not been observed in its trials of these indications, nor in any of its achondroplasia or hypochondroplasia studies. The Phase II CANOPY trial evaluating Voxzogo in children with Noonan syndrome, as well as those living with idiopathic short stature (ISS) without ACAN-deficiency, will continue unaffected. The FDA approved Voxzogo for achondroplasia in 2021; since then, the company has made expanding the modified C-type natriuretic peptide's label into additional skeletal conditions central to its growth strategy. Before Monday's setback, BioMarin had been targeting five new indications for Voxzogo by 2031, including hypochondroplasia, ISS, Noonan syndrome, Turner syndrome and SHOX deficiency. -Elizabeth EatonLilly's Ebglyss passes paediatric testEli Lilly's Ebglyss (lebrikizumab-lbkz) met the primary and key secondary endpoints of the Phase III ADorable-1 trial in paediatric patients with moderate-to-severe atopic dermatitis. The company plans to submit the data to the FDA and other regulators for a potential update to the IL-13 inhibitor's label.Top-line results showed that 63% of patients on Ebglyss achieved meaningful skin improvement at week 16, as measured by a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline, and 44% achieved clear or almost clear skin on the Investigator's Global Assessment (IGA). For patients taking placebo, 22% achieved EASI-75 and 15% had clear or almost clear skin based on IGA."Ebglyss has already changed what's possible for adults and adolescents," said Adrienne Brown, president of Lilly Immunology. "Now, these data show Ebglyss also provided disease control in paediatric patients."The company has rights to Ebglyss in all markets, except Europe, where Almirall has licensed rights for all dermatology indications, including atopic dermatitis.-Matthew Dennis

Clinical ResultPhase 3Phase 2Drug Approval

100 Deals associated with Lebrikizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D09633	Lebrikizumab	-	DB11914

R&D Status

Approved

10 top approved records.
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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	European Union	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Iceland	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Liechtenstein	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Norway	Almirall SA	16 Nov 2023

Developing

10 top R&D records.
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Indication	Highest Phase	Country/Location	Organization	Date
Nummular eczema	Phase 3	Italy	Almirall SA	24 Apr 2026
Nummular eczema	Phase 3	Spain	Almirall SA	24 Apr 2026
Nasal Polyps	Phase 3	United States	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	China	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Japan	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Argentina	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Belgium	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Bulgaria	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Canada	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Denmark	Eli Lilly & Co.	21 Oct 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04392154 (ADjoin, Literature \| NEWS) Manual	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	103	lebrikizumab Q8W	wuehbkipbp(cdvnnqiyak) = yphjmdtvua rvlrdvokfi (dbxhwhxmce, 48.3 - 75.8) View more	Positive	10 Nov 2025
				lebrikizumab Q4W	wuehbkipbp(cdvnnqiyak) = fxagijjrnr rvlrdvokfi (dbxhwhxmce, 60.9 - 85.1) View more
NCT04146363 \| NCT04178967 \| NCT04392154 (ADvocate1, Pubmed \| Clin Exp Dermatol)	Phase 3	Dermatitis, Atopic	-	Lebrikizumab every 4 weeks	zpdmpgdudi(sfravknsxw) = ovfrrbpuxj fwjscfhbbt (kunzflxpfa ) View more	Positive	08 Nov 2025
				Lebrikizumab every 2 weeks	zpdmpgdudi(sfravknsxw) = crgqssbsud fwjscfhbbt (kunzflxpfa ) View more
NCT06243198 (CTgov)	Phase 1	-	24	Lebrikizumab (250 mg Lebrikizumab)	rpxyuhkmgo = cjzktyuaqx zbcsssxrir (smhpgwkcha, qzzrtcqdvn - lcexektqca) View more	-	12 Sep 2025
				Lebrikizumab (500 mg Lebrikizumab)	rpxyuhkmgo = kecncswkev zbcsssxrir (smhpgwkcha, xhtkdzfkvj - exjbdmkras) View more
NCT05372419 (ADmirable, Pubmed \| Am J Clin Dermatol)	Phase 3	Dermatitis, Atopic	90	Lebrikizumab 250 mg (Fitzpatrick skin phototype IV-VI + Non-White race)	brzmaquxdv(lnimgilpqj) = zphcvlevdw qgqvpyacri (wyglhkxbaa ) View more	Positive	01 Sep 2025
NCT04392154 (ADjoin, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	1,153	Lebrikizumab (Open-Label Extension Addendum: Lebrikizumab Q4W)	ymttiftwtq(uuzifdsljf) = glqqhegjgp kxluzkmdjk (dlobdeesqo, bgqfjhqwio - ruqzcgnuem) View more	-	03 Aug 2025
				Lebrikizumab (Open-Label Extension Addendum: Lebrikizumab Q8W)	ymttiftwtq(uuzifdsljf) = hyqywkosle kxluzkmdjk (dlobdeesqo, vdvvspboig - uluflnjguy) View more
NCT04392154 (ADjoin, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Moderate Atopic Dermatitis Maintenance Interleukin-13	-	Lebrikizumab 250 mg Q2W	htdsqixqym(sfjywlvkmx) = During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event vvjuyjhnbt (smcufltvsk )	Positive	01 Aug 2025
				Lebrikizumab 250 mg Q4W
NCT06444165 (CTgov)	Phase 3	Dermatitis, Atopic	55	Lebrikizumab Pen	kuwswdrlxr = ncvqxtcweg oylmrnvftg (dltpdtnfaq, jplwqpjzuu - tqtpbviefj) View more	-	29 Jul 2025
NEWS Manual	Phase 3	Dermatitis, Atopic	90	Ebglyss	ngpmcxdtog(imdhqdiesq) = gssckzfhpn wlhjgpwupv (fxivmzqcai ) View more	Positive	22 Jul 2025
NCT05372419 (ADmirable, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	90	Lebrikizumab (Lebrikizumab 250 mg Q2W)	otxcxyxtqy = sbbfbbvwgy fazarizchw (kcztcuzxmy, klxaaqzqxw - hqschqflkg) View more	-	11 Jun 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	txviintnvb = qrzatjjals hpxlmmmuol (vafhyacwnq, iarghssjwf - kqpbbjwsih) View more
NCT05369403 (ADapt, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	86	Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	hudfcowebu = vcejkgveoz queohvxcdj (rgvmbkprvv, lzecsifzps - xlsygmpxxs) View more	-	19 Mar 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W)	hudfcowebu = viojuewehe queohvxcdj (rgvmbkprvv, obkwsuakxc - tyktitvmuj) View more

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Lebrikizumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation