Delving into the Latest Updates on Delgocitinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CORECTIM® Ointment 0.25%, CORECTIM® Ointment 0.5%, Delgocitinib (JAN/USAN)

+ [10]

Target

JAK

Mechanism

JAK inhibitors(Janus kinase inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Chronic eczemaDermatitis, AtopicMandibulofacial Dysostosis+ [4]

Inactive Indication

Allergic skin reactionAlopecia AreataLupus Erythematosus, Discoid+ [4]

Originator Organization

Japan Tobacco (Hong Kong) Ltd.

Active Organization

Japan Tobacco, Inc.

Leo Pharma, Inc.

LEO Pharma A/S

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (23 Jan 2020),

Dermatitis, Atopic

Regulation-

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Structure/Sequence

Molecular FormulaC16H18N6O

InChIKeyLOWWYYZBZNSPDT-ZBEGNZNMSA-N

CAS Registry1263774-59-9

AbstractBackgroundThe Hand Eczema Severity Index (HECSI) is a Clinician‐Reported Outcome measure of the severity of hand eczema (HE).ObjectivesThis study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI‐75 and HECSI‐90 as responder definitions.MethodsAnalyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double‐blind, vehicle‐controlled trial of delgocitinib cream, pooled across treatment groups. The measurement properties of the HECSI were assessed and the adequacy of the HECSI‐75 and HECSI‐90 as responder definitions was explored through cross‐tabulation.ResultsInter‐item correlations provided support for the scoring, whereby items are grouped by areas of the hand. HECSI demonstrated good test–retest reliability with intra‐class correlations >0.70. Construct validity was supported by a logical pattern of correlations with concurrent measures and significant differences in HECSI scores across severity groups (p < 0.001). HECSI was responsive with statistically significant improvements over time and with significant differences (p < 0.001) between improved and stable groups. Data provided support for both HECSI‐75 and HECSI‐90 as within‐patient responder definitions.ConclusionsHECSI has strong validity, reliability and ability to detect change as a measure of CHE severity. HECSI‐75 and HECSI‐90 are appropriate responder definitions.

01 Dec 2024·Clinical & Experimental Allergy

Topical Anti‐Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta‐Analysis

Review

Author: Doyle, Megan ; Drucker, Aaron M. ; Lax, Stephanie J. ; Boyle, Robert J. ; Parker, Roses ; Williams, Hywel C. ; Candy, Bridget ; Reynolds, Clare ; Futamura, Masaki ; Chu, Derek K. ; Axon, Emma ; Stuart, Beth ; Steele, Lloyd ; Van Vogt, Eleanor ; Roberts, Amanda ; Cro, Suzie ; Santer, Miriam

ABSTRACTObjectiveEczema is the most burdensome skin condition worldwide and topical anti‐inflammatory treatments are commonly used to control symptoms. The relative effectiveness and safety of different topical anti‐inflammatory treatments is uncertain.DesignNetwork meta‐analysis performed within a Cochrane systematic review to compare and statistically rank efficacy and safety of topical anti‐inflammatory eczema treatments.Data SourcesCochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries to June 2023.Eligibility Criteria for Selected TrialsIncluded trials were within‐participant or between‐participant randomised controlled trials. Participants had eczema that was not clinically infected and was not contact dermatitis, seborrheic eczema or hand eczema. Interventions were topical anti‐inflammatory treatments but not complementary treatments, antibiotics alone, wet wraps, phototherapy or systemic treatments. Comparators were no treatment/vehicle or another topical anti‐inflammatory.ResultsWe identified 291 trials (45,846 participants), mainly in high‐income countries. Most were industry‐funded with median 3 weeks treatment duration. Risk of bias assessed using the Cochrane Risk of Bias 2.0 tool was high in 89% of trials, mainly due to risk of selective reporting. Network meta‐analysis of binary outcomes ranked potent and/or very potent topical steroids, tacrolimus 0.1% and ruxolitinib 1.5% among the most effective treatments for improving patient‐reported symptoms (40 trials, all low confidence) and clinician‐reported signs (32 trials, all moderate confidence). For investigator global assessment, the Janus kinas inhibitors ruxolitinib 1.5%, delgocitinib 0.5% or 0.25%, very potent/potent topical steroids and tacrolimus 0.1% were ranked as most effective (140 trials, all moderate confidence). Continuous outcome data were mixed. Local application site reactions were most common with tacrolimus 0.1% (moderate confidence) and crisaborole 2% (high confidence) and least common with topical steroids (moderate confidence). Skin thinning was not increased with short‐term use of any topical steroid potency (low confidence) but skin thinning was reported in 6/2044 (0.3%) participants treated with longer‐term (6–60 months) topical steroids.ConclusionPotent topical steroids, Janus kinase inhibitors and tacrolimus 0.1% were consistently ranked as among the most effective topical anti‐inflammatory treatments for eczema.

01 Nov 2024·The Journal of Dermatology

Effective treatment of topical corticosteroid‐resistant dermatitis with delgocitinib in a pediatric patient with Netherton syndrome

Letter

Author: Yonekura, Satoru ; Teraoka, Marina ; Murata, Teruasa ; Nakajima, Saeko ; Takegami, Tomoya ; Kabashima, Kenji ; Egawa, Gyohei

A review.A review discussing effective treatment of topical corticosteroid-resistant dermatitis with delgocitinib in a pediatric patient with netherton syndrome.It also discusses that topical delgocitinib could be a promising option for treating eczema in NS when topical corticosteroids are ineffective.

40

News (Medical) associated with Delgocitinib

13 Jan 2025

·pmlive.com

Gilead and LEO enter inflammatory disease partnership worth up to $1.7bn

Gilead Sciences and LEO Pharma have entered into a strategic partnership worth $1.7bn to advance LEO’s small molecule oral STAT6 programme for inflammatory diseases. The deal gives Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US. In exchange, LEO will be eligible for up to $1.7bn, including an upfront payment of $250m and approximately $1.5bn in development, regulatory and commercial milestones. LEO may also receive tiered royalties on sales of oral STAT6 products, while Gilead could be in line for tiered royalties on sales of topical STAT6 products. Flavius Martin, executive vice president, research, Gilead, said the company is “committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block major pathogenic pathways, eliminate pathogenic cells, tolerise the immune system, and restore cell function”. “By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring forward an oral option for patients suffering from chronic inflammatory conditions,” he added. STAT6 is the specific transcription factor used for interleukin-4 and interleukin-13 cytokine signalling, which has been shown to play a key role in multiple inflammatory conditions, including atopic dermatitis, asthma and chronic obstructive pulmonary disease. The approach has already shown potential pre-clinically to treat a broad population of patients and provide an oral alternative to those currently receiving injectable biologics. “STAT6 holds potential for treating various inflammatory diseases, including outside dermatology,” said LEO’s chief executive officer, Christophe Bourdon. “This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 programme and maximise its potential in dermatology and beyond.” The announcement comes just over a month after LEO’s Anzupgo (delgocitinib) cream was approved by the Medicines and Healthcare Products Regulatory Agency to treat chronic hand eczema in adults with moderate-to-severe cases of the inflammatory skin disease. The company is now working with the National Institute for Health and Care Excellence to make the treatment available on the NHS.

Drug ApprovalLicense out/in

05 Dec 2024

·www.pharmaceutical-technology.com

LEO Pharma’s eczema cream gains MHRA marketing authorisation

Anzupgo (delgocitinib) 20mg/g cream is intended to treat moderate to severe chronic hand eczema in adults. Credit: Kmpzzz/Shutterstock. Leo Pharma has gained marketing authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its topical pan-Janus kinase (JAK) inhibitor, Anzupgo (delgocitinib) 20mg/g cream, to treat chronic hand eczema (CHE) in Britain. The approval enables the treatment of adults with moderate to severe CHE when topical corticosteroids are inadequate or inappropriate. The decision was based on the positive outcomes of the Phase III programme, which encompassed the DELTA 1 and DELTA 2 trials. The trials assessed the cream’s efficacy and safety against a cream vehicle, meeting their primary and secondary goals. Subjects from the DELTA 1 and DELTA 2 trials were given the opportunity to join the DELTA 3 trial, a 36-week open-label extension study. LEO Pharma UK and Ireland vice-president and general manager Leanne Walsh stated: “Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe chronic hand eczema. “This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.” The cream targets the JAK-STAT signalling pathway involved in CHE pathogenesis. The condition is marked by skin barrier dysfunction, inflammation and changes in the skin microbiome. The current approval of delgocitinib cream adds to its existing authorisations in the European Union and Switzerland for the same indication. LEO Pharma obtained exclusive development and commercialisation rights to the cream for dermatological uses globally, excluding Japan, through a license agreement with Japan Tobacco (JT) in 2014. JT holds the rights in Japan. In September 2024, the European Commission (EC) granted marketing authorisation for delgocitinib cream to treat adults with moderate to severe CHE. LEO Pharma UK and Ireland is working with the National Institute for Health and Care Excellence ( Nice ) to ensure the cream’s availability on the National Health Service (NHS). Chronic hand eczema is a complex and variable inflammatory skin condition, with primary symptoms such as itching and pain affecting the hands and wrists.

Phase 3Drug ApprovalLicense out/inClinical Result

05 Dec 2024

·pmlive.com

LEO Pharma’s Anzupgo cream granted MHRA approval to treat chronic hand eczema

LEO Pharma has announced that its Anzupgo (delgocitinib) cream has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat chronic hand eczema (CHE). The treatment has been specifically authorised for use in adults with moderate-to-severe cases of the inflammatory skin disease for whom topical corticosteroids are inadequate or inappropriate. CHE is defined as hand eczema that lasts for more than three months or relapses at least twice within a year. Alongside physical symptoms such as itch and pain, the condition has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients with severe cases reporting problems performing everyday activities. LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE, and is now the first topical pan-JAK inhibitor treatment approved by the MHRA specifically for adults with moderate-to-severe CHE. The UK regulator’s decision, which comes less than three months after the European Commission approved Anzupgo for the same indication, was supported by positive results from the phase 3 DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream. The primary endpoint, Investigator’s Global Assessment for CHE treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16. Data from the 36-week DELTA 3 open-label extension trial also informed the approval. Leanne Walsh, vice president and general manager, LEO Pharma UK and Ireland, said the approval “marks a significant milestone for adults in Great Britain living with moderate-to-severe CHE”. Also commenting on the authorisation, Richard Warren, consultant dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester, said: “The physical symptoms of CHE can be debilitating, substantially disrupting patients’ lives… [The] approval of a first, topical JAK inhibitor treatment option for moderate-to-severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” LEO said it is now “collaborating closely” with the National Institute for Health and Care Excellence to make Anzupgo cream available on the NHS.

Phase 3Drug ApprovalClinical Result

100 Deals associated with Delgocitinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D11046	-	D11AH	DB16133

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic eczema	IS	LEO Pharma A/S	19 Sep 2024
Chronic eczema	LI	LEO Pharma A/S	19 Sep 2024
Chronic eczema	NO	LEO Pharma A/S	19 Sep 2024
Chronic eczema	EU	LEO Pharma A/S	19 Sep 2024
Dermatitis, Atopic	JP	Japan Tobacco, Inc.	23 Jan 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic eczema	NDA/BLA	US	Leo Pharma, Inc.	23 Sep 2024
Mandibulofacial Dysostosis	Phase 3	CN	LEO Laboratories Ltd.	05 Sep 2023
Mandibulofacial Dysostosis	Phase 3	CN	Shanghai Leo Pharmaceutical Consulting Co., Ltd.	05 Sep 2023
Mandibulofacial Dysostosis	Phase 3	CN	LEO Pharma A/S	05 Sep 2023
Eczema, Dyshidrotic	Phase 3	DK	LEO Pharma A/S	30 Jan 2022
Eczema, Dyshidrotic	Phase 3	DK	Japan Tobacco, Inc.	30 Jan 2022
Frontal Fibrosing Alopecia	Phase 2	-	Japan Tobacco, Inc.	-
Frontal Fibrosing Alopecia	Phase 2	DK	LEO Pharma A/S	-
Alopecia Areata	Preclinical	US	Leo Pharma, Inc.	01 Jan 2016
Alopecia Areata	Discovery	US	Leo Pharma, Inc.	01 Jan 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05259722 (BusinessWire) Manual	Phase 3	Chronic eczema	513	Delgocitinib cream	wsmlgjcoly(xbipmqeaab) = ncurhcrxlx kfmuafubpd (ztxjllapbd ) Met View more	Positive	25 Sep 2024
				Alitretinoin capsules	wsmlgjcoly(xbipmqeaab) = npmmlmvynk kfmuafubpd (ztxjllapbd ) Met View more
NCT04872101 \| NCT04871711 (DELTA 2, Pubmed) Manual	Phase 3	Eczema	-	Delgocitinib cream 20 mg/g	(qwckzyyzud) = btrxqhxtmh mumyycbzsf (kgwmntwqox ) View more	Positive	01 Jul 2024
				Cream vehicle	(qwckzyyzud) = seexxvoqpa mumyycbzsf (kgwmntwqox ) View more
NCT04949841 (DELTA 3, BusinessWire) Manual	Phase 3	Chronic eczema	801	Delgocitinib cream	(eukuitgrsq) = COVID-19 and nasopharyngitis wukjelmhdp (tqwqsazfld )	Positive	10 Mar 2024
NCT04949841 (DELTA 3, NEWS) Manual	Phase 3	Eczema, Dyshidrotic	-	delgocitinib	(wjzxesgxtl) = safety profile of twice-daily treatment with delgocitinib cream for up to 36 weeks was consistent with previous results from DELTA 1 and 2. rybtuephtz (tlntsxjuib ) View more	Positive	31 Oct 2023
NCT04872101 (DELTA 2, NEWS) Manual	Phase 3	Eczema, Dyshidrotic	473	Delgocitinib	(tozrifdxwm) = gsvonlnqfh qaqlxoazrz (xakqrjveaf ) View more	Positive	13 Oct 2023
				cream vehicle	(tozrifdxwm) = gpovafovln qaqlxoazrz (xakqrjveaf ) View more
NCT04872101 (DELTA 2, EADV2023)	Phase 3	Eczema, Dyshidrotic	-	Delgocitinib cream 20 mg/g	whegelnxvk(vajkudeupv) = tcpumgvfsn prhyrawuxu (cqxaziivmq )	-	11 Oct 2023
NCT04871711 (DELTA 1, EADV2023)	Phase 3	Eczema, Dyshidrotic	487	Delgocitinib cream 20 mg/g	yxjxbhzkmc(zlcekdiqwl) = zkqsvjvvxr vjtiattnwo (zkpplpgzht ) View more	Positive	11 Oct 2023
				Cream vehicle	yxjxbhzkmc(zlcekdiqwl) = jhkfwruafl vjtiattnwo (zkpplpgzht ) View more
NCT04872101 \| NCT04871711 (DELTA 1 and DELTA 2, EADV2023)	Phase 3	Chronic eczema	639	Delgocitinib cream 20 mg/g	zkiqeechqj(avytzenyiw): difference = 0.11 (95% CI, 0.08 - 0.13)	Positive	11 Oct 2023
				Cream vehicle
NCT04872101 (DELTA 2, EADV2023)	Phase 3	Eczema, Dyshidrotic	-	Delgocitinib cream 20 mg/g	byoomekfto(avllevpfak) = tztdagmbxg olejozrpqh (qofxnbqyye ) View more	Positive	11 Oct 2023
				Cream vehicle	byoomekfto(avllevpfak) = kxzmxwvozs olejozrpqh (qofxnbqyye ) View more
NCT04871711 (DELTA 1, BusinessWire) Manual	Phase 3	Chronic eczema	487	delgocitinib	(cskzvkqvap) = at least a two-step improvement from baseline ebhrhhtmcu (xzdqckftga )	Positive	06 Dec 2022
				Vehicle