Delving into the Latest Updates on Apadamtase alfa /Cinaxadamtase alfa with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

ADAMTS13, recombinant-krhn, Recombinant ADAMTS13, 阿帕达酶α辛奈达酶α

+ [9]

Target

vWFCP

Action

modulators

Mechanism

vWFCP modulators(ADAM metallopeptidase with thrombospondin type 1 motif 13 modulators), Enzyme replacements

Therapeutic Areas

Hemic and Lymphatic DiseasesOther DiseasesNervous System Diseases+ [1]

Active Indication

Congenital Thrombotic Thrombocytopenic PurpuraAcute Ischemic StrokeThrombotic Thrombocytopenic Purpura, Acquired

Inactive Indication

Anemia, Sickle Cell

Originator Organization

The Chemo-Sero-Therapeutic Research Institute

Active Organization

Clinical Supplies Management Europe SATakeda Pharmaceuticals U.S.A., Inc.

Clinigen Clinical Supplies Management

+ [5]

Inactive Organization

Baxalta, Inc.

Shire Plc

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Nov 2023),

Congenital Thrombotic Thrombocytopenic Purpura

RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (Australia), Rare Pediatric Disease (United States)

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Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible.
The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking.
The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Start Date17 May 2026

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06441578

/ RecruitingNot Applicable

Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation)

This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.
During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.

Start Date30 May 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT05714969

/ CompletedPhase 2

A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in the Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response in Part 1 or platelet response in Part 2. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

Start Date21 Jul 2023

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Apadamtase alfa /Cinaxadamtase alfa

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100 Translational Medicine associated with Apadamtase alfa /Cinaxadamtase alfa

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100 Patents (Medical) associated with Apadamtase alfa /Cinaxadamtase alfa

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111

Literatures (Medical) associated with Apadamtase alfa /Cinaxadamtase alfa

28 May 2026·BLOOD

Thrombotic thrombocytopenic purpura: celebrating 25 years of ADAMTS13

Review

Author: Carter, Matthew A. ; Subhan, Maryam ; Scully, Marie

Abstract:

Thrombotic thrombocytopenic purpura (TTP) was first described just over a century ago, and it is now 25 years since the identification of ADAMTS13 as the enzyme deficient in both antibody-mediated immune TTP (iTTP) and congenital TTP (cTTP). The discovery of ADAMTS13 has been fundamental to the vast improvement seen in TTP outcomes. Understanding the interaction between ADAMTS13, platelets, and von Willebrand factor led to the development of clinical ADAMTS13 assays, and therefore quicker and accurate diagnosis, but also, critically, to novel therapies and monitoring of treatment. Landmark additions to iTTP therapy have included anti-CD20 treatment with rituximab, in both the acute and elective settings, and the use of the nanobody caplacizumab in acute TTP. In cTTP, the use of ADAMTS13 replacement is playing a role in reducing end-organ damage and morbidity, with recombinant ADAMTS13 (rADAMTS13) now representing the gold standard for cTTP. The ability to measure response to treatment by monitoring ADAMTS13 activity has underpinned these treatment advances, and allowed clinicians to tailor immunosuppressive treatment for iTTP and rADAMTS13 dosing in cTTP. Looking forward, there are many avenues for future development, with potential expansion of rADAMTS13 to treat iTTP, new, quicker assays to improve diagnosis, monitoring, and immunomodulatory therapeutic advancement, all underpinned by ADAMTS13. Future endeavors for the role of ADAMTS13 in other thrombotic indications open further exciting opportunities.

10 Mar 2026·Blood Advances

Optimizing ADAMTS13 prophylaxis to reduce relapse and organ failure in congenital thrombotic thrombocytopenic purpura

Article

Author: Joly, Bérangère S. ; Jacobs, Frédéric ; Kwon, Theresa ; Parquet, Nathalie ; Bouzid, Raïda ; Provôt, François ; Saheb, Samir ; Joseph, Adrien ; Vigneau, Cécile ; Laurent, Gilardin ; Zunic, Patricia ; Barbay, Virginie ; Joly, Bérangère ; Simon, Ville ; Servais, Aude ; Benhamou, Ygal ; Provôt, Françoi ; Gouge-Biebuyck, Nathalie ; Ulrich, Marc ; Ronchetti, Anne-Marie ; Grangé, Steven ; Wynckel, Alain ; Ojeda Uribe, Mario ; Pouteil-Noble, Claire ; Chatelet, Valérie ; Delmas, Yahsou ; Stépanian, Alain ; Perez, Pierre ; Barbet, Christelle ; Coindre, Jean-Philippe ; Azoulay, Elie ; Sellier-Leclerc, Anne-Laure ; Dossier, Antoine ; Dossier, Claire ; Frémeaux-Bacchi, Véronique ; Marie, Manon ; Chauveau, Dominique ; Boisseau, Pierre ; Ribes, David ; Presne, Claire ; Guidet, Bertrand ; Veyradier, Agnès ; Martis, Nihal ; Choukroun, Gabriel ; Le Quintrec, Moglie ; Kaplanski, Gilles ; Benoît, Suzon ; Hertig, Alexandre ; Le Guern, Véronique ; Moulin, Bruno ; Virginie, Rieu ; Pène, Frédéric ; Poullin, Pascale ; Seguin, Amélie ; Tsatsaris, Vassilis ; Laurent, Mesnard ; Coppo, Paul ; Arnaud, Jaccard ; Celia, Salanoubat ; Rebibou, Jean-Michel ; Kanouni, Tarik ; Harambat, Jérôme ; Veyradier, Agnè ; Krummel, Thierry ; Galicier, Lionel ; Charvet-Rumpler, Anne ; Ducheyron, Damien ; Kwon, Thérésa ; Boyer, Olivia ; Augusto, Jean-François ; Moranne, Olivier ; Halimi, Jean-Michel ; Antoine, Neel

Abstract:

Congenital thrombotic thrombocytopenic purpura (cTTP) is caused by a severe inherited ADAMTS13 (a disintegrin and metalloprotease with thrombospondin type 1 motif, member 13) deficiency. Although acute episodes are life-threatening, long-term burden of ischemic complications, and effectiveness of prophylactic strategies remain underexplored. We conducted a 25-year national, multicenter study of 88 patients with cTTP enrolled in the French Thrombotic Microangiopathy registry. Patients were stratified by age and clinical context at disease onset: pediatric (n = 42), pregnancy (n = 33), and adult onset (n = 13). Clinical features, genotypes, treatment regimens, and long-term ischemic outcomes were analyzed. Pediatric patients exhibited early-onset disease (median age at diagnosis, 2 years [interquartile range, 0-13]) with recurrent episodes and a high burden of neurological complications. In patients with pregnancy-onset disease, no relapses were observed outside pregnancy. Adult-onset patients, typically diagnosed aged >50 years, showed prevalent cardiovascular disease, stroke, and kidney injury. Mental health disorders were common across all groups. Despite long-term plasma prophylaxis, organ dysfunction persisted, particularly in pediatric- and adult-onset groups. In pregnancy-onset cTTP, tailored midterm prophylaxis during pregnancy reduced maternal and fetal complications. Thirty-nine patients received recombinant human ADAMTS13 (rhADAMTS13) prophylaxis (median follow-up, 5 months [interquartile range, 6-17]). Prophylactic treatment significantly improved relapse-free survival, with a comparable outcome using intensive plasma-derived products and rhADAMTS13 in pediatric-onset cases, although adverse events were more prevalent using plasma therapy. Our findings highlight the clinical and genetic heterogeneity of cTTP and the burden of organ dysfunction. Intensive prophylaxis improves relapse-free survival. rhADAMTS13 represents a safe and promising first-line option that should help reduce long-term organ damage and improve quality of life.

01 Feb 2026·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Microthrombi growth in ADAMTS13 deficiency exacerbates inflammatory bowel disease via mucosal and endothelial dysfunction

Article

Author: Suzuki, Yuko ; Urano, Tetsumei ; Honkura, Naoki ; Kokame, Koichi ; Kurachi, Kiyotaka ; Sugimoto, Ken ; Takeuchi, Hiroya ; Sakata, Mayu ; Tatsuta, Kyota ; Morooka, Nanami

BACKGROUND:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by mucosal inflammation and ulceration. While von Willebrand factor, typically cleaved by ADAMTS13 from ultralarge multimers into smaller fragments, has been found to accumulate in the inflamed lesions of the ADAMTS13-deficient colitis model, the association between aberrant thrombus formation in lesional microvessels and colitis exacerbation remains unclear.

OBJECTIVES:

We investigated potential linkages between microthrombus formation and colitis progression.

METHODS:

Plasma and inflamed colonic tissues from patients with UC were analyzed. We employed intravital multiphoton microscopy to reveal the real-time structural dynamics of the mucus layer and mucosal vasculature at single-cell spatial resolution in a dextran sulfate sodium-induced colitis model of wild-type and ADAMTS13-deficient green fluorescent protein-expressing mice.

RESULTS:

Patients with UC exhibited significantly reduced plasma ADAMTS13 activity and excessive von Willebrand factor deposition in inflamed colonic tissues. In dextran sulfate sodium-induced colitis mice, ADAMTS13 deficiency showed heightened disease activity and increased mucosal erosion in histochemical analysis compared with wild-type mice. A novel methodology appraised colonic mucus barrier integrity by visualizing fluorescent dextran penetration from the colonic lumen to crypts. ADAMTS13 deficiency accelerated mucus layer disruption, leukocyte recruitment, and microthrombus formation, particularly in periepithelium regions. Vessel-specific analyses demonstrated that obstructive microthrombi were most prominent in the mucosal layer, contributing to local ischemia and mucosal erosion. Recombinant human ADAMTS13 alleviated microthrombus formation, improved mucosal integrity, and mitigated colitis severity in both wild-type and ADAMTS13-deficient mice.

CONCLUSION:

Advanced intravital imaging analysis revealed that obstructive thrombi formed in mucosal vessels due to impaired ADAMTS13 activity were essential for colitis severity.

78

News (Medical) associated with Apadamtase alfa /Cinaxadamtase alfa

10 Sep 2026

·www.fiercebiotech.com

Takeda’s long-serving R&D chief Andy Plump to retire in wake of pipeline successes

Andy Plump, M.D., Ph.D., president of research and development at Takeda, is set to leave the company in June. Plump joined the Japanese drugmaker in 2015, arriving from Sanofi to initially serve as chief medical and scientific officer. Now, Plump has announced plans to retire from Takeda. The executive will continue to lead the R&D team until a successor is appointed and will then work with the new leader to smooth the transition before leaving the company next year. News of Plump’s departure follows the development of molecules intended to drive growth at Takeda after a period in which the loss of exclusivity on ADHD drug Vyvanse dragged on sales. Last month, the company won FDA approvals for narcolepsy treatment Orzeyful and blood cancer drug Mimrylo . Having recently shared positive phase 3 data on zasocitinib in psoriasis, Takeda is poised to add the TYK2 inhibitor to its stable of recently approved medicines. Since 2021, the company has won approval for the antiviral Livtencity , the blood clotting disorder drug Adzynma and the eosinophilic esophagitis therapy Eohilia . Plump’s successor will inherit the challenge of continuing to launch new growth drivers to offset the loss of exclusivity on the inflammatory bowel disease drug Entyvio. While the recent approvals point to the success of some of Plump’s preparations for competition from Entyvio biosimilars, other R&D initiatives overseen by the outgoing executive have failed to deliver the hoped-for results. Notably, Takeda’s play for the cell therapy market fizzled out, with the company exiting the modality last year and taking an impairment loss on its 2021 takeover of GammaDelta Therapeutics. A Crohn’s disease cell therapy, Alofisel, which Takeda acquired in its takeover of TiGenix, reached the European market but was withdrawn in the aftermath of a phase 3 failure .

Phase 3Cell TherapyExecutive ChangeDrug ApprovalAcquisition

13 May 2026

·endpoints.news

Takeda to target 4,500 jobs as incoming CEO continues restructuring

Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in its fourth-quarter earnings presentation. That figure doesn’t account for hiring plans, including 2,200 roles that are currently open and new jobs that will be created throughout the year, a Takeda spokesperson told Endpoints News. No further details were shared about the timeline and which roles will be affected. Takeda is the latest biopharma to announce four-digit layoffs, following Novo Nordisk’s September 2025 decision to cut 9,000 jobs and Merck’s July announcement targeting 6,000 positions. Bayer CEO Bill Anderson confirmed this month that it’s made 14,000 reductions as part of a broader restructuring. Takeda’s outgoing CEO Christophe Weber laid out plans in 2024 to simplify the company’s structure, remove layers and broaden roles. Incoming CEO Julie Kim also cited efficiency as a priority as she prepares to take the reins in June. Going forward, Takeda said it would prioritize resources to advance its late-stage pipeline, including three products that Kim hopes will be blockbusters: the narcolepsy drug oveporexton, the blood cancer drug rusfertide, and a plaque psoriasis drug called zasocitinib. The FDA is currently mulling applications for oveporexton and rusfertide, with decisions expected in the third quarter of the calendar year. Meanwhile, Takeda made a handful of pipeline cuts last quarter, including a Phase 1 program for nausea and vomiting called TAK-004 and a Phase 2b program for the enzyme replacement therapy TAK-755 in immune thrombotic thrombocytopenic purpura. The Japanese pharma cited strategic reasons for both cuts. Takeda also returned the rights for a frontotemporal dementia candidate called TAK-594 to Denali after severing the partnership . The company is also discontinuing a booster program for its dengue vaccine Qdenga after data suggested additional dosing wasn’t needed for sustained protection.

VaccinePhase 2Phase 1

13 May 2026

·www.fiercebiotech.com

Takeda 0 for 4 against nausea and vomiting after axing another asset

At the start of 2022, Takeda was developing three peptide agonists in nausea and vomiting.\n Takeda has ended development of its nausea and vomiting drug candidate for strategic reasons, continuing its multi-year struggles in the therapeutic area. The nausea and vomiting prospect, TAK-004, completed a phase 1 trial last year. Takeda ran the study to evaluate the safety and tolerability of the investigational peptide agonist while evaluating its effect on the heart rate and blood pressure of healthy adults. The Japanese drugmaker named assessing whether TAK-004 causes an immune response as another objective of the trial.Takeda removed (PDF) the drug candidate from its pipeline as part of its fourth-quarter results, telling investors that it ended TAK-004 development “due to strategic consideration.” The company’s strategy has veered away from nausea and vomiting in recent years.At the start of 2022, Takeda was developing (PDF) three peptide agonists—TAK-105, TAK-510 and TAK-951—in nausea and vomiting, plus its gastroparesis candidate TAK-906. Takeda stopped (PDF) work on the treatment for gastroparesis, a condition associated with nausea and vomiting, early in 2022 in response to phase 2b data. The drugmaker ended (PDF) development of TAK-510 in late 2022 after concluding that the phase 1 data didn’t support further trials. Takeda reached (PDF) the same conclusion about TAK-105 in 2023. Work on the phase 2 candidate TAK-951 continued into 2024. However, in May 2024, Takeda axed the program after the clinical data failed to support further development. The removal of TAK-951 from the pipeline left Takeda without a program targeting nausea and vomiting for the first time in years. Takeda moved (PDF) TAK-004 into human testing in late 2024, re-entering nausea and vomiting clinical development, but the candidate had the same fate as its predecessors. Takeda continues \"to have interest in nausea and vomiting where we see meaningful unmet need,\" a spokesperson said via email.The drugmaker disclosed the discontinuation of TAK-004 development alongside other pipeline updates. The Japanese pharma removed the 5% formulation of TAK-961, its late-phase autoimmune encephalitis candidate, from the pipeline but still plans to seek approval for the 10% product. Data on the 5% formulation will support approval filings for the 10% product, the company said.Takeda removed the Denali Therapeutics-partnered frontotemporal dementia candidate, TAK-594, from its pipeline after ending its alliance with the biotech. The other updates affected approved products, with Takeda ending a booster program for its dengue vaccine Qdenga in light of durability data and axing a proposed indication for the enzyme replacement therapy Adzynma for strategic reasons.

VaccinePhase 2Phase 1PDC

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Congenital Thrombotic Thrombocytopenic Purpura	United States	Takeda Pharmaceuticals U.S.A., Inc.	09 Nov 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 2	United States	Clinigen Clinical Supplies Management	17 May 2026
Acute Ischemic Stroke	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	17 May 2026
Acute Ischemic Stroke	Phase 2	China	Takeda Pharmaceutical Co., Ltd.	17 May 2026
Acute Ischemic Stroke	Phase 2	China	Clinigen Clinical Supplies Management	17 May 2026
Acute Ischemic Stroke	Phase 2	Japan	Takeda Pharmaceutical Co., Ltd.	17 May 2026
Acute Ischemic Stroke	Phase 2	Japan	Clinigen Clinical Supplies Management	17 May 2026
Acute Ischemic Stroke	Phase 2	Belgium	Clinigen Clinical Supplies Management	17 May 2026
Acute Ischemic Stroke	Phase 2	Belgium	Takeda Pharmaceutical Co., Ltd.	17 May 2026
Acute Ischemic Stroke	Phase 2	Brazil	Clinigen Clinical Supplies Management	17 May 2026
Acute Ischemic Stroke	Phase 2	Brazil	Takeda Pharmaceutical Co., Ltd.	17 May 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03393975 (ASH2025)	Phase 3	Congenital Thrombotic Thrombocytopenic Purpura	48	rADAMTS13	afvdofqzbl(tpuhqfywnw) = hkegwgdniv dokpqnynen (nhfdepyfzc ) View more	Positive	06 Dec 2025
				PBT	sduxmdlulq(cwlninwqcc) = ntcxamyovq baxhetuosy (kjjkckcfxw ) View more
NCT03393975 (phase 3, ASH2024)	Phase 3	Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13 enzyme \| VWF total protein antigen \| VWF activity	36	rADAMTS13	xsrnxnrvxa(iwcevuuctj) = cqtpfdbmws dwcwndwswi (shxcodmzei, -29.5 to to 2.4)	Positive	09 Dec 2024
				Plasma-based therapies (PBT)	xsrnxnrvxa(iwcevuuctj) = wuuttfxoyx dwcwndwswi (shxcodmzei, -13.3 to 3.5)
ASH2024	-	Purpura, Thrombotic Thrombocytopenic	14	Apadamtase alfa	cwgkxweuco(bcimtqfzcx) = ovkarlgslm uouokyotre (iihxohduvw )	Positive	07 Dec 2024
NCT03393975 (Pubmed \| N Engl J Med) Manual	Phase 3	Congenital Thrombotic Thrombocytopenic Purpura ADAMTS13	32	Recombinant ADAMTS13	tdwdgpijpt(fbpmlwafqt) = idycffztje tgyjgmohso (jhxpksbjna ) View more	Positive	02 May 2024
				Standard Therapy (plasma-derived products)	tdwdgpijpt(fbpmlwafqt) = ikzswsnkak tgyjgmohso (jhxpksbjna ) View more
NCT03997760 (RAISE, CTgov)	Phase 1	Anemia, Sickle Cell	19	Placebo	qxvicaxsdz = oemlaxjswg ubcaptzreo (gekgemozyo, mstxpxmiau - tiklaeondm) View more	-	23 Apr 2024
NCT03997760 (ASH2023)	Phase 1	Anemia, Sickle Cell	19	rADAMTS13	dxcwjaxhki(dfbipokxbk) = ugohchivua ywsscvjbaa (zknhbyrlpg ) View more	Positive	09 Dec 2023
FDA Manual	Not Applicable	Congenital Thrombotic Thrombocytopenic Purpura	86	ADZYNMA	yptfzntaan(samoguebwr) = tkhthqtzti rtwjlhfgnz (glnbkuzusa ) View more	Positive	09 Nov 2023
				Plasma-Based Therapies	yptfzntaan(samoguebwr) = lcjvfkzbfe rtwjlhfgnz (glnbkuzusa, 0.304) View more
NCT03922308 (EHA2023)	Phase 2	Thrombotic Thrombocytopenic Purpura, Acquired	28	Placebo	lbrazoacsz(hlslfrxolq) = ozpdsumtft zrcawzcpye (jffuffbqvr )	-	08 Jun 2023
				rADAMTS13 40 IU/kg IV	lbrazoacsz(hlslfrxolq) = neufhxcwqu zrcawzcpye (jffuffbqvr )
NCT03922308 (SOAR-HI, CTgov)	Phase 2	Thrombotic Thrombocytopenic Purpura, Acquired	28	Placebo (Standard of Care (SoC) + Placebo)	fktslwxuqv(dpeqjepiej) = cyqxqmkpst xxirpksqex (ygfumylvso, 0.19247) View more	-	01 Dec 2022
				Placebo+SHP655 (SoC + SHP655 + Placebo)	fktslwxuqv(dpeqjepiej) = xztfqdpkyj xxirpksqex (ygfumylvso, NA) View more

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