Delving into the Latest Updates on Duvakitug with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

SAR-447189, SAR447189, TEV 48574

+ [5]

Target

TL1A

Action

inhibitors

Mechanism

TL1A inhibitors(Tumor necrosis factor superfamily member 15 inhibitors)

Therapeutic Areas

Immune System DiseasesDigestive System Disorders

Active Indication

Colitis, UlcerativeCrohn DiseaseCrohn's disease, active moderate+ [3]

Inactive Indication

Asthma

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization

SanofiTeva Branded Pharmaceutical Products R&D LLCSanofi-Aventis Recherche & Développement SA

+ [2]

Inactive Organization-

License Organization

Teva Pharmaceutical Industries Ltd.

Blackstone Life Sciences, LLC

Sanofi

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 13306596H

Source: *****

Sequence Code 13306598L

Source: *****

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
* 40-week Pivotal Maintenance Sub-Study
* 240-week Open-Label Extension (OLE) Sub-Study
* 45-day Follow-Up visit
Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
* 40 weeks in the Pivotal Maintenance Sub-Study
* 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Start Date22 Jan 2026

Sponsor / Collaborator

Sanofi

[+1]

NCT07185009

/ RecruitingPhase 3

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
Study details include:
The study duration may be up to 286 weeks including:
* 40-week Pivotal Maintenance Sub-Study
* 240-week Open-Label Extension (OLE) Sub-Study
* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
* 40 weeks in Pivotal Maintenance Sub-Study
* 240 weeks in OLE Sub-Study
The total number of on-site visit will be up to 32:
* 21 visits in the Pivotal Maintenance Sub-Study.
* 11 visits in the OLE Sub-Study.

Start Date16 Jan 2026

Sponsor / Collaborator

Sanofi

[+1]

100 Clinical Results associated with Duvakitug

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100 Translational Medicine associated with Duvakitug

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100 Patents (Medical) associated with Duvakitug

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2

Literatures (Medical) associated with Duvakitug

01 Mar 2025·Revue medicale de Liege

[Intestinal fibrosis in Crohn's disease : towards new therapeutic options?]

Review

Author: Vieujean, Sophie ; Stepniak, Marty ; Louis, Édouard ; Meuwis, Marie-Alice ; Bequet, Émeline

Crohn's disease is a chronic inflammatory bowel disease that can lead to fibrostenotic complications. These strictures result from an imbalance between inflammation and excessive healing, leading to an abnormal accumulation of extracellular matrix and a progressive thickening of the intestinal wall. To date, no specific treatment is available to prevent or reverse intestinal fibrosis. The management of strictures primarily focuses on controlling inflammation and addressing obstructive complications through endoscopic balloon dilation, stricturoplasty, or intestinal resection. Current medical therapies, such as anti-TNF agents, can help reduce inflammation but have no direct impact on fibrosis. New therapeutic strategies are emerging, including TL1A inhibitors (duvakitug, tulisokibart), an ALK5 inhibitor (AGMB-129), and targeted AGR2 therapies (TH-009). Additionally, mesenchymal stem cells are being investigated in our hospital center in combination with endoscopic balloon dilation, aiming to assess their therapeutic potential. The development of effective anti-fibrotic therapies remains a critical medical need to improve the management of intestinal strictures and reduce the need for invasive procedures in Crohn's disease.

01 May 2024·Med (New York, N.Y.)

TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis

Review

Author: Vipul Jairath ; Laurent Peyrin-Biroulet ; Federica Ungaro ; Silvio Danese ; Virginia Solitano

The pivotal role of TL1A in modulating immune pathways crucial for inflammatory bowel disease (IBD) and intestinal fibrosis offers a promising therapeutic target. Phase 2 trials (TUSCANY and ARTEMIS-UC) evaluating an anti-TL1A antibody show progress in expanding IBD therapeutic options. First-in-human data reveal reduced expression of genes associated with extracellular matrix remodeling and fibrosis post-anti-TL1A treatment. Investigational drug TEV-48574, potentially exerting dual antifibrotic and anti-inflammatory effects, is undergoing a phase 2 basket study in both ulcerative colitis (UC) and Crohn disease (CD). Results are eagerly awaited, marking advancements in IBD therapeutics. This critical review comprehensively examines the existing literature, illuminating TL1A and the intricate role of DR3 in IBD, emphasizing the evolving therapeutic landscape and ongoing clinical trials, with potential implications for more effective IBD management.

60

News (Medical) associated with Duvakitug

31 Mar 2026

·www.pharmaceutical-technology.com

Blackstone closes largest ever private funding investment round at $6.3bn

BXLS funds innovation within the life sciences sector. Credit: Vector mall / Shutterstock.com. Private investment platform Blackstone closed a funding raise that has brought in $6.3bn in capital to support its ongoing life sciences investment strategy – marking the largest life sciences private fund ever raised. The firm’s dedicated BXLS platform will absorb this oversubscribed funding round, providing companies with capital to develop and commercialise new drugs and medical technologies across the entire lifecycle. In the last 12 months, BXLS has handed over nearly $2bn to various companies within the life sciences sector to fund their development and commercialisation journeys. This includes MSD (Merck & Co), which recently bagged $700m to support the development of its antibody-drug conjugate (ADC), sacituzumab tirumotecan , across various solid tumour indications. BXLS also poured $400m into Teva Pharmaceutical’s duvakitug development programme back in early March 2026, which is currently in late-stage trials for inflammatory bowel diseases like Crohn’s and ulcerative colitis. In February 2026, the investment platform teamed up with Johnson & Johnson (J&J) to co-fund future clinical trials of its acute myeloid leukaemia (AML) drug, bleximenib. Blackstone Life Sciences has previously secured 34 approvals for innovative medicines and devices it has backed, including blockbuster therapies like Alnylam Pharmaceuticals’ transthyretin amyloidosis (ATTR) therapy, Amvuttra (vutrisiran) and AbbVie & J&J’s Bruton’s tyrosine kinase (BTK) inhibitor, Imbruvica (ibrutinib). Taking a look at the life sciences investment landscape According to Blackstone Life Sciences’ global head, Nicholas Galakatos, this round highlights the firm’s “enduring conviction in the life sciences”, which remains one of its core areas of focus. This will be welcome news for the sector, which has been contending with a challenging funding landscape triggered by burgeoning interest rates and economic uncertainty in recent years. Geopolitical factors like tariffs are also currently shaping pharmaceutical investment and launch strategies . Despite these hurdles, there have been some positive signals hinting to the recovery of pharma funding. As per a report from GlobalData , parent company of Pharmaceutical Technology , the total value of venture capital investments made in the sector in Q4 2025 climbed 70.6% compared with Q3. This upward trend was also observed in the volume of investments, which saw a 30.4% uptick to 206 deals. GlobalData has also highlighted the shift in investor activity – especially in the cell and gene therapy (CGT) space – which has seen an enhanced interest in candidates in the Series B-stage , as investors become more selective and strategy-driven. In a previous conversation with Pharmaceutical Technology , LanceBio Ventures partner, Ilya Yasny, noted that early planning, adaptability, trust building and strong data make up the backbone of any successful startup, and that companies should always look to fulfil an unmet patient need.

Drug ApprovalADC

30 Mar 2026

·www.fiercebiotech.com

Blackstone closes record $6.3B life sciences fund

The fund tops Blackstone\'s own BLXS V, which raised $4.6 billion in 2020.\n One of the world’s leading investment firms has broken its own record with the closing of its $6.3 billion Blackstone Life Sciences VI (BLXS VI) fund, which is 40% larger than its predecessor.According to a March 30 release, the oversubscribed fund closed at its hard cap and is the largest private fund ever dedicated to life sciences. Since its launch in 2018, Blackstone Life Sciences has grown to manage $15 billion in assets.Blackstone portfolio companies have produced 34 regulatory approvals for medicines and devices, the firm said. These include Novartis’ cholesterol treatment Leqvio, Alnylam’s transthyretin-mediated (ATTR) amyloidosis drug Amvuttra and Pharmacyclics’ chronic lymphocytic leukemia therapy Imbruvica.In a statement, Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, said the fund’s record “highlights how we work successfully with industry trailblazers to help bring their most important products to patients around the world.” Blackstone reported that BLXS investments have achieved an 86% approval success rate for phase 3 assets. Over the past 12 months, the platform has made $2 billion in new investments, including $400 million to support Teva’s Sanofi-partnered IBD drug duvakitug and $700 million for Merck’s antibody-drug conjugate sacituzumab tirumotecan.In July 2020, Blackstone reached its fundraising target for BLXS V, raising $4.6 billion to support late-stage product development and growth investments in emerging companies.

ADCAcquisitionDrug Approval

30 Mar 2026

·firstwordpharma.com

Blackstone's sixth fund closes at record-breaking $6.3B

Blackstone Life Sciences said Monday that it has closed its latest fund, BXLS VI, at $6.3 billion, marking the largest private fund ever raised for the life sciences. The oversubscribed raise surpasses the firm's fifth fund, closed in July 2020, by about $1.7 billion. According to Blackstone, the capital will be used to support new therapeutics and technologies "with the potential to transform patients' lives." It boasted that Phase III assets backed by its BXLS programme have an 86% approval rate. As of the fourth quarter of 2025, Blackstone had $15 billion in assets under management. In the past year, the firm has committed close to $2 billion, supporting specific experimental treatments being developed by big pharmas. It handed over $700 million to Merck & Co. for its TROP2-targeting antibody-drug conjugate sacituzumab tirumotecan (sac-TMT), which is being studied in 15 global Phase III studies across six tumour types, including breast, endometrial and lung cancers (see – Vital Signs: Merck & Co. ups the ante for its big bet on sac-TMT).Johnson & Johnson also received an investment backing bleximenib (JNJ-75276617), an oral menin inhibitor in development for acute myeloid leukaemia, while Teva pocketed $400 million to support ongoing work on duvakitug, an anti-TL1A mAb being co-developed and co-commercialised with Sanofi.Some of Blackstone's other notable deals include launching cardiovascular-focused startup Anthos Therapeutics with Novartis in 2019; last year, Novartis elected to bring Anthos back into the fold in a deal worth potentially more than $3 billion. And in 2020, the private equity fund put $2 billion behind Alnylam's RNAi medicines engine."Our partnerships with global leaders have produced 34 regulatory approvals of innovative medicines and devices," said Nicholas Galakatos, global head of Blackstone. "This track record highlights how we work successfully with industry trailblazers to help bring their most important products to patients around the world."

ADCPhase 3

100 Deals associated with Duvakitug

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 3	United States	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	China	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Japan	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Bulgaria	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Canada	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Czechia	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	France	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Germany	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Hungary	Sanofi	08 Oct 2025
Colitis, Ulcerative	Phase 3	Lithuania	Sanofi	08 Oct 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05499130 (RELIEVE UCCD, CTgov)	Phase 2	Crohn Disease \| Colitis, Ulcerative	290	placebo+TEV-48574 (Placebo (UC))	xsrozhrnqs = wlumesnmlb rvmakhjint (djesqlczom, vqgjjzdhda - qezlvljorl) View more	-	05 Dec 2025
				TEV-48574 (TEV-48574 450 mg (UC))	xsrozhrnqs = zmbpwewpvy rvmakhjint (djesqlczom, lrsmadwawv - kubguivzlc) View more
NCT05499130 (RELIEVE UCCD, NEWS \| Company_Website 1 \| Company_Website 2) Manual	Phase 2	Crohn Disease \| Colitis, Ulcerative	240	duvakitug (UC + 450 mg)	gqqmewfpvz(umxecflxtg) = qtptwoezrv abgfnhymhl (zoaokdckwn ) Met View more	Positive	17 Dec 2024
				duvakitug (UC + 900 mg)	gqqmewfpvz(umxecflxtg) = qxpiwwkihy abgfnhymhl (zoaokdckwn ) Met View more
NCT04545385 (CTgov)	Phase 2	Asthma	65	Placebo (Placebo)	ygdezbfiel = vaavzipjup diiwldulxd (sizkddsije, uycylgyjlf - sgapgkdkqc) View more	-	13 Mar 2023
				TEV-48574 (TEV-48574)	ygdezbfiel = fydndoxhuf diiwldulxd (sizkddsije, lhlzuwdjvy - rhoqlngxck) View more

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