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)

+ [13]

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, AtopicChronic rhinosinusitis with nasal polypsRhinitis, Allergic, Perennial+ [3]

Inactive Indication

airway diseaseAirway ObstructionAllergic asthma+ [4]

Originator Organization

Genentech, Inc.

Active Organization

Almirall SA

Eli Lilly & Co.Eli Lilly Canada, Inc.

+ [3]

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: *****

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.
Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Start Date01 Jun 2025

Sponsor / Collaborator

Eli Lilly & Co.

NCT06906497

/ Not yet recruitingPhase 4IIT

Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis

This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Michigan

[+2]

NCT06921759

/ RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis.
This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

Start Date21 Apr 2025

Sponsor / Collaborator

Eli Lilly & Co.

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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185

Literatures (Medical) associated with Lebrikizumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Rosacea-like skin reaction under treatment with dupilumab for atopic dermatitis

Article

Author: Augustin, M. ; Wagner, J. N. ; Zirkenbach, F. ; Grote, C.

PURPOSE:

Dupilumab is a widely recommended treatment for moderate-to-severe atopic dermatitis (AD), with known ocular side effects but less frequent cutaneous reactions.

MATERIAL AND METHODS:

This case report details a 52-year-old female patient with atopic dermatitis treated with dupilumab. After an initially successful treatment, the patient developed a rosacea-like dermatitis. At first, dupilumab was continued alongside doxycycline, metronidazole gel and ivermectin cream.

RESULTS:

Following a worsening of her skin condition, dupilumab was discontinued. Lebrikizumab was introduced, leading to significant regression of the lesions.

CONCLUSIONS:

This case highlights a rare paradoxical skin reaction to dupilumab, potentially linked to the blockade of IL-4Rα, which may shift the immune response towards a Th1/Th17 phenotype. The findings suggest that alternative therapies, such as IL-13 inhibitors, should be considered when cutaneous side effects arise during dupilumab treatment.

21 Jun 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Reply to 'Real-world experience of switching from tralokinumab to lebrikizumab in atopic dermatitis'.

Letter

Author: Martora, Fabrizio ; Napolitano, Maddalena ; Patruno, Cataldo

01 Jun 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Focused update: Guidelines of care for the management of atopic dermatitis in adults

Article

Author: Davis, Dawn M R ; Darr, Jennifer M ; Alikhan, Ali ; Schwarzenberger, Kathryn ; Cohen, David E ; Silverberg, Jonathan I ; Frazer-Green, Lindsy ; Eichenfield, Lawrence F ; Drucker, Aaron M ; Paller, Amy S ; Singh, Anne Marie ; Sidbury, Robert ; Bercovitch, Lionel ; Wu, Peggy A

BACKGROUND:

In 2023 and 2024, the American Academy of Dermatology published guidelines on the use of topical and systemic therapies for the management of atopic dermatitis (AD) in adults. Since the publication of these guidelines, several novel therapies have emerged to treat AD.

OBJECTIVE:

To update previous guidelines on the management of AD in adults by providing evidence-based recommendations on the use of additional Food and Drug Administration-approved topical and systemic therapies.

METHODS:

A multidisciplinary workgroup conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations.

RESULTS:

The workgroup developed 4 new recommendations for the management of AD in adults.

LIMITATIONS:

This analysis is based on the best available evidence at the time it was conducted. Most randomized controlled trials of the considered therapies for AD are of short duration, limiting comparative long-term efficacy and safety conclusions.

CONCLUSIONS:

The workgroup developed strong recommendations for the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab with concomitant topical therapy.

153

News (Medical) associated with Lebrikizumab

20 May 2025

·www.fiercepharma.com

As Eli Lilly outperforms Novo in market, it also replaces its rival in annual IDEA Innovation rankings

Eli Lilly and AstraZeneca landed at the top of IDEA Pharma's annual Innovation Index and Invention Index rankings, respectively. As Eli Lilly and Novo Nordisk continue to go in opposite directions in their diabetes and obesity market rivalry, so too have they changed positions in the annual IDEA Pharma Innovation Index, which ranks (PDF) the most transformative companies in the biopharma industry.While Lilly advanced from fourth place in 2024 to the top spot this year, it has supplanted last year's champion Novo, which tumbled all the way to eighth place. It’s a familiar perch for Lilly, which earned IDEA’s No. 1 slot in 2019 and 2021.This is the 14th year that IDEA, a pharmaceutical industry consulting firm based in London, has conducted the analysis. In 2019, IDEA added an annual Invention Index, which was topped by AstraZeneca for the third time in the last four years.In conducting its Innovation ranking, IDEA asks two questions: Who in the industry is at the forefront of innovation and what are they doing to achieve this? Additionally, if two biopharma companies were given the same molecule in early phase, which would better develop and launch it and why?In ranking Lilly No. 1, IDEA cited the FDA approvals of obesity drug Zepbound for obstructive sleep apnea, Kisunla for Alzheimer’s disease and Ebglyss for atopic dermatitis, each of which came in the second half of 2024.IDEA also recognized Lilly’s $3.2 billion buyout of Morphic to expand its immunology portfolio and its creation of the LillyDirect platform, which “reflects the company’s commitment to improving patient access and affordability by streamlining therapy delivery and reducing insulin costs.”On the flip side, in addition to falling into No. 8 on the Innovation Index, Novo plummeted to last place in the Invention Index. In both categories, IDEA ranks the industry’s top 30 companies.Novo’s declining fortunes are reflected in a market cap slide from $640 billion in July of last year to its present figure of $293 billion. Last week, the company announced the departure of eight-year CEO Lars Fruergaard Jørgensen. Also receiving high marks in the Innovation rankings were No. 2 Merck, which jumped from the 10th slot largely because of the continued progression of the development of megablockbuster Keytruda. Third-place AZ and fourth-place Roche rose from Nos. 7 and 8, respectively, while Pfizer, which claimed consecutive titles in 2022 and 2023 for its rapid development of COVID-19 products, came in at No. 5. Also making notable jumps were No. 6 Regeneron, from 15th place, No. 7 UCB, which vaulted from outside of the top 20, and No. 10 Novartis, which was up from 17th place.UCB’s leap was fueled by “significant advancements in immunology, neurology and rare diseases,” IDEA wrote, citing advancements with Bimzelx in inflammatory conditions. "With a pipeline that spans high-need therapeutic areas, UCB has re-established itself as a resilient and innovative player, leveraging differentiated biologics and cutting-edge research to address unmet patient needs,” IDEA CEO Mike Rea said in a release.While IDEA’s Innovation Index measures how well companies perform in bringing new medicines to market and commercializing them, its Invention Index examines the breadth and depth of novel agents currently being developed within the top 30 pharma pipelines. The Invention Index provides a more forward-looking view of who is developing medicines that matter, embracing science and innovations in R&D. AZ’s recent dominance of the category is owed to its deep portfolio across several disease areas, including oncology, evidenced by the success and additional potential of blockbusters Tagrisso, Imfinzi and Enhertu across multiple cancer types.AZ replaced Johnson & Johnson in the top spot, with J&J falling to second place this year, one notch in front of Moderna. As they did in the Innovation Index, Roche and Regeneron also made significant leaps, from No. 17 and No. 8, respectively, last year, to tie for fourth place. Jumping from the teens into the top 10 were No. 8 GSK, as well as BeiGene and Boehringer Ingelheim, which tied for 10th place. Others in the Invention Index top 10 were No. 6 Lilly, No. 7 Merck and No. 9 Pfizer.In addition to Novo placing last in the Invention Index, others who performed poorly in the rankings were Merck KGaA, which placed No. 30 in Innovation and No. 26 in Invention. Takeda also was in the bottom five in both categories. Bayer, Biogen, AbbVie and Otsuka were in the bottom 10 in both categories.

AcquisitionDrug Approval

17 Mar 2025

·www.pharmaceutical-technology.com

Incyte stock hit 11% despite paediatric dermatology trials hitting target

The US-based company’s Stop-HS1 and Stop-HS2 trials hit their primary endpoints with both doses of povorcitinib. Credit: Shutterstock / Kristi Blokhin. Incyte’s stock price has taken a hit of more than 11%, despite two Phase III trials investigating its oral small-molecule JAK1 inhibitor in hidradenitis suppurativa (HS) hitting their primary endpoints. The US-based company’s Stop-HS1 (NCT05620823) and Stop-HS2 (NCT05620836) trials hit their primary endpoints with both doses of povorcitinib, 45mg and 75mg, with a higher proportion of patients treated with the therapy. This achieved a Hidradenitis Suppurativa Clinical Response (HiSCR), which is defined as more than 50% from baseline in the total abscess and inflammatory nodule count. After 12 weeks of treatment, in the Stop-HS1 trial, 40.2% of patients receiving 45mg povorcitinib saw HiSCR versus 29.7% in the placebo group while patients in the 75mg cohort saw similar results with 40.6% achieving HiSCR. Results in the Stop-HS2 trial saw similar rates with patients in the 45mg group seeing 42.3% HiSCR rates versus the same percentile in the 75mg group. At the same time, the trials met key secondary endpoints, including the proportion of patients achieving a 75% reduction in inflammatory nodule count. Both studies included a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week extension period and a 30-day safety follow-up period. Despite this, the company’s stock price has taken a hit of more than 11%, dropping from $67.72 before the announcement, down to $60.72 per share at the time of publication (11am EST, 17 March). The studies each enrolled approximately 600 children across more than 100 international sites diagnosed with moderate to severe HS for at least three months before a screening visit, who presented with more than five lesions in at least two different anatomical areas. Incyte’s chief medical officer Steven Stein said: “HS is a challenging and debilitating condition without a cure. Given the limitations of current HS treatments and their impact on patients’ daily lives, there is a critical need for new, well-tolerated and effective therapies that provide a rapid reduction in the signs and symptoms of HS, in particular, pain. “The positive Phase III data highlights the potential of povorcitinib as an effective oral treatment option for people living with HS.” Assuming povorcitinib makes it to market, research by GlobalData’s Pharmaceutical Intelligence Center estimates that it is likely to bring in $34m by the end of 2026, with that figure estimated to rise to $625m by the end of 2030. GlobalData is the parent company of Clinical Trials Arena . The company is now planning to use these results to advance regulatory submissions worldwide. Away from HS, the company is examining povorcitinib in a Phase III trial in vitiligo, as well as an ongoing Phase II trial in asthma. Elsewhere in the field of skin conditions, Eli Lilly’s Ebglyss (lebrikizumab-lbkz) has achieved complete skin clearance after three years in 50% of patients with moderate-to-severe atopic dermatitis (AD). Meanwhile, Bambusa Therapeutics has announced the dosing of its first healthy volunteers as part of a Phase I trial on its half-life extended bispecific antibody therapy for AD.

Phase 3Clinical ResultPhase 2Phase 1Immunotherapy

10 Mar 2025

·www.fiercebiotech.com

Amgen ignites Rocket program with phase 3 wins for $400M eczema prospect

Amgen paid Kyowa Kirin $400 million upfront for rights to rocatinlimab in 2021.\n Amgen’s $400 million eczema drug candidate has recorded two more phase 3 victories. The data drops provide more evidence that the Kyowa Kirin-partnered rocatinlimab improves outcomes in atopic dermatitis, but questions about the positioning of the anti-OX40 antibody versus Sanofi and Regeneron’s Dupixent remain unanswered.Last year, Amgen and Kyowa shared the first data from its broad phase 3 rocatinlimab program. The study met its primary endpoint, but analysts compared the results unfavorably to the data on Dupixent. Adjusted for placebo, 19.1% of people on rocatinlimab had 75% improvement in eczema area and severity after 24 weeks of treatment. The comparable figures from Dupixent trials are as high as 36% after 16 weeks.Amgen sees an opportunity for a drug with a different mechanism of action, citing evidence about how often patients stop or switch therapies. Saturday, the Big Biotech and Kyowa presented results to make the case that rocatinlimab can seize that opportunity.The latest data come from Ignite and Shuttle, two trials from Amgen and Kyowa’s broader Rocket program. Ignite randomized 769 adults with moderate to severe eczema, including an undisclosed number of patients previously treated with a biologic or systemic JAK inhibitor, to receive one of two doses of rocatinlimab or placebo. The high dose was identical to the only dose used in the earlier phase 3 trial. On the high dose, 42.3% of patients met the 75% improvement criteria, EASI-75. The placebo-adjusted EASI-75 was 29.5%. The lower dose was less effective, but the result was still numerically higher than in the earlier phase 3, with a placebo-adjusted difference of 23.4%. Jefferies analysts said in a note to investors that the results are “optically more compelling” than the earlier data.The other study, Shuttle, randomized 746 adults with moderate to severe eczema to receive one of two doses of rocatinlimab or placebo. Again, the high dose was the same dose used in the earlier phase 3 trial. Participants in Shuttle also received topical corticosteroids and/or topical calcineurin inhibitors. The placebo-adjusted EASI-75 results were 28.7% and 30.4%, respectively, on the low and high doses.Amgen, which paid Kyowa $400 million upfront for rights to rocatinlimab in 2021, also reported wins on two versions of an investigator eczema assessment scale in Ignite and Shuttle. Safety was generally consistent with the profile seen in earlier studies, according to Amgen and Kyowa.“In totality, the rocatinlimab results validate the OX40 mechanism, likely supporting a moderate commercial opportunity for patients after Dupixent/Ebglyss,” William Blair analysts said in a March 10 note.However, the readouts “still leave potential room for improvement with future OX40/OX40L targeting therapies,” added the analysts, pointing to Inmagene\'s OX40-targeting monoclonal antibody IMG-007.Three more readouts are coming up. Amgen and Kyowa are aiming to publish phase 3 results from Ascend, a trial that is assessing dosing beyond 24 weeks, and the adolescent Astro study in the second half of the year. A second trial in adolescent patients, Orbit, is underway, as are phase 2 and 3 trials in asthma and prurigo nodularis. The studies are testing the idea that rocatinlimab rebalances the T-cell compartment.

Phase 3Clinical ResultPhase 2Phase 1Financial Statement

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
Chronic rhinosinusitis with nasal polyps	Phase 3	United States	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	China	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Japan	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Belgium	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Bulgaria	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Canada	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Denmark	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Germany	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Italy	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Poland	Eli Lilly & Co.	29 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05372419 (ADmirable, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	90	Lebrikizumab	bchoobxqgm = ebuwdwhwfh hwxsehldrp (uviwrrskqx, sdziwuzcex - vovqothcsl) View more	-	11 Jun 2025
NCT05369403 (ADapt, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	86	Lebrikizumab (Lebrikizumab 250mg Q2W)	smyuacysbs = msimogxhoh pctwfwfcvr (yfgylqibso, tsxkhddhvg - doeejsufot) View more	-	19 Mar 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	hzhljlgcgu = badlonlhza kwhaivnpmp (kgjkozgfap, zfyxjrwxdr - bhbtxkrsnt) View more
NCT04146363 \| NCT04178967 (Pubmed)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	-	Lebrikizumab	xeptglsntp(adzywthqct) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders ovswntqwnz (rxfizfnavg )	Positive	31 Dec 2024
NCT04760314 (ADhere-J, Pubmed) Manual	Phase 3	Dermatitis, Atopic	286	Placebo + TCS	vxpcdgqnug(xaycbjfeiq) = pnwoegzuan pwidnrnamg (rgxvhcploi ) View more	Positive	03 Dec 2024
				Lebrikizumab 250 mg Q4W + TCS	vxpcdgqnug(xaycbjfeiq) = gknxiuwjse pwidnrnamg (rgxvhcploi ) View more
NCT04840901 (CTgov)	Phase 1	-	242	Lebrikizumab (Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD))	rnvgbgytdv(ncdusvedpc) = czesyaclgl afzavyoxnz (osmftxmeqq, 31) View more	-	22 Nov 2024
				Lebrikizumab (Test) (Lebrikizumab (Test) - Autoinjector (AI))	rnvgbgytdv(ncdusvedpc) = mftlgrxyof afzavyoxnz (osmftxmeqq, 31) View more
NCT04146363 \| NCT04178967 (ADvocate1, ADvocate2, ACAAI2024)	Phase 3	Dermatitis, Atopic Maintenance	-	Lebrikizumab every 2 weeks (LEBQ2W)	qlrdlbtnfx(rqqxehjoqe) = wuyjxxtohc ywgqjxyhoe (rntzbvuxtu ) View more	Positive	24 Oct 2024
				Lebrikizumab every 4 weeks (LEBQ4W)	qlrdlbtnfx(rqqxehjoqe) = zfekmodleb ywgqjxyhoe (rntzbvuxtu ) View more
NCT04760314 (Pubmed) Manual	Phase 3	Dermatitis, Atopic	271	lebrikizumab + topical corticosteroids (TCS) (maintenance primary population)	makpaxzdoy(xzlbkhowhy) = fgnammvuoc hvffnokaks (iownrkqimg ) View more	Positive	23 Oct 2024
				lebrikizumab + topical corticosteroids (TCS) (maintenance escape population)	makpaxzdoy(xzlbkhowhy) = julllbkbfv hvffnokaks (iownrkqimg ) View more
NCT04146363 \| NCT04178967 (FDA_CDER) Manual	Phase 3	Dermatitis, Atopic	851	EBGLYSS 250 mg Q2W (ADvocate 1)	drjduexrjs(bybowqcwem) = plcdywmttb esukyubzqr (okytauhecl ) View more	Positive	13 Sep 2024
				Placebo (ADvocate 1)	drjduexrjs(bybowqcwem) = lpixqrjqce esukyubzqr (okytauhecl ) View more
NCT04146363 \| NCT04178967 (ADvocate2, Pubmed \| Adv Ther) Manual	Phase 3	Dermatitis, Atopic	-	Lebrikizumab 250 mg	hfzvpyirmu(hpootlfuwv) = bqcsmylvjc lgezbarwea (rcccntmqgx ) View more	Positive	09 Sep 2024
				Placebo	hfzvpyirmu(hpootlfuwv) = basjygxhlm lgezbarwea (rcccntmqgx ) View more
NCT04146363 \| NCT04178967 (ADvocate1;ADvocate2, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Severe Atopic Dermatitis Maintenance	-	Lebrikizumab Q2W	knfcpcestz(crdsljhhsa) = lbqrgpspep tlbcuwgbus (owrnoakugy ) View more	Positive	01 Aug 2024
				Lebrikizumab Q4W	knfcpcestz(crdsljhhsa) = vqpuitspiw tlbcuwgbus (owrnoakugy ) 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