Atacicept
| Clinical data | |
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| Trade names | Trutakna |
| Other names | atacicept-vymj |
| AHFS/Drugs.com | trutakna |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C3104H4788N856O950S44 |
| Molar mass | 70708.13 g·mol−1 |
Atacicept, sold under the brand name Trutakna, is a medication used for the treatment of proteinuria in immunoglobulin A nephropathy.[1] It is given via subcutaneous injection (under the skin).[2] Atacicept was developed by Merck KGaA.[3]
Atacicept was approved for medical use in the United States in July 2026.[4] Atacicept is the first medication that targets both B-cell activating factor and a proliferation-inducing ligand (APRIL), which are involved in survival and maturation of certain immune cells.[2] This in turn decreases production of the abnormal immunoglobulin A antibody.[2]
Medical uses
[edit]Atacicept is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.[2]
Immunoglobulin A nephropathy is a serious kidney disease that occurs when an abnormal form of an immunoglobulin A antibody builds up in the kidneys, causing kidney inflammation and damage.[2] This kidney damage can cause protein to leak from the blood into the urine (proteinuria) and loss of kidney function over time that may progress to kidney failure.[2]
Pharmacology
[edit]Mechanism of action
[edit]Atacicept is a fusion protein of the human transmembrane activator, calcium modulator, and cyclophilin ligand interactor (TACI) receptor and the Fc portion of human IgG1 (TACI Fc), which has been modified to reduce Fc receptor-mediated effector functions.[1] This blood-soluble protein can bind two cytokines that regulate maturation, function, and survival of B cells – B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), with the constant region of immunoglobin.[5]
Atacicept is thought to selectively impair mature B cells and plasma cells with less impact on progenitor cells and memory B cells.[6]
Manufacturing
[edit]Atacicept is produced by recombinant DNA technology in Chinese hamster ovary cells. [1]
History
[edit]The efficacy and safety of atacicept were evaluated in a randomized, double-blind, placebo-controlled clinical trial (NCT04716231) in adult participants with biopsy-confirmed IgA nephropathy.[2] Participants were randomly assigned to either atacicept 150 mg injected subcutaneously once weekly or placebo.[2]
Society and culture
[edit]Legal status
[edit]Atacicept was approved for medical use in the United States in July 2026.[7] The US Food and Drug Administration (FDA) granted the application for atacicept priority review and breakthrough therapy designations.[2] The FDA granted the approval of Trutakna to Vera Therapeutics.[2]
Names
[edit]Atacicept is the international nonproprietary name.[8]
Atacicept is sold under the brand name Trutakna.[1]
References
[edit]- 1 2 3 4 5 "Trutakna- atacicept injection, solution". DailyMed. 6 July 2026. Retrieved 20 July 2026.
- 1 2 3 4 5 6 7 8 9 10 "FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy". U.S. Food and Drug Administration (FDA). 7 July 2026. Retrieved 11 July 2026.
This article incorporates text from this source, which is in the public domain. - ↑ "Merck KGaA, Darmstadt, Germany, Announces Out-Licensing Agreement for Investigational Atacicept with Vera Therapeutics" (Press release). Merck KGaA. 9 November 2020. Retrieved 11 July 2026 – via EMD Group.
- ↑ "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 29 July 2026. Retrieved 4 August 2026.
- ↑ Hartung HP, Kieseier BC (July 2010). "Atacicept: targeting B cells in multiple sclerosis". Therapeutic Advances in Neurological Disorders. 3 (4): 205–16. doi:10.1177/1756285610371146. PMC 3002656. PMID 21179612.
- ↑ Nestorov I, Munafo A, Papasouliotis O, Visich J (April 2008). "Pharmacokinetics and biological activity of atacicept in patients with rheumatoid arthritis". Journal of Clinical Pharmacology. 48 (4): 406–17. doi:10.1177/0091270008315312. PMID 18303125. S2CID 11540779.
- ↑ "Vera Therapeutics Receives FDA Accelerated Approval for Trutakna for Adult Patients with Primary IgA Nephropathy" (Press release). Vera Therapeutics. 7 July 2026. Retrieved 11 July 2026 – via GlobeNewswire.
- ↑ World Health Organization (2007). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 57". WHO Drug Information. 21 (1). hdl:10665/74004.
Further reading
[edit]- Sharma I, Panta R (December 2025). "Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine". Cureus. 17 (12) e99870. doi:10.7759/cureus.99870. PMC 12823202. PMID 41573494.
- Tian Z, Yang Y, Huang M, Fang Z, Mei J, Li Y, et al. (December 2025). "Efficacy and safety of BAFF/APRIL dual antagonists in IgA nephropathy: a systematic review and meta-analysis of randomized controlled trials". BMC Nephrology. 27 (1) 55. doi:10.1186/s12882-025-04689-w. PMC 12821315. PMID 41402784.
External links
[edit]- "Atacicept ( Code - C81166 )". EVS Explore.
- Clinical trial number NCT04716231 for "Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)" at ClinicalTrials.gov
