Atacicept
| Clinical data | |
|---|---|
| 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.[2] Atacicept was developed by Merck KGaA.[3] It is given via subcutaneous injection (under the skin).[4]
Atacicept was approved for medical use in the United States in July 2026.[2] 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.[4] This in turn decreases production of the abnormal immunoglobulin A antibody.[4]
Medical uses
[edit]Atacicept is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.[4]
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.[4] 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.[4]
Pharmacology
[edit]Mechanism of action
[edit]The protein combines the binding site for two cytokines that regulate maturation, function, and survival of B cells – B-lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL), with the constant region of immunoglobin.[5] Atacicept blocks activation of B cells by the tumor necrosis factor receptor superfamily member 13B (more commonly known as TACI), a transmembrane receptor protein found predominantly on the surface of B cells. Like the monoclonal antibody belimumab, atacicept blocks the binding of BLyS, but it also blocks APRIL. Binding of these TACI ligands induces proliferation, activation, and longevity of B cells and thus their production of autoantibodies.[6] Atacicept is thought to selectively impair mature B cells and plasma cells with less impact on progenitor cells and memory B cells.[7]
History
[edit]The efficacy and safety of atacicept were evaluated in a randomized, double-blind, placebo-controlled clinical trial (NCT04716231) in adults with biopsy-confirmed IgA nephropathy.[4] Participants were randomly assigned to either atacicept 150 mg injected subcutaneously once weekly or placebo.[4]
Society and culture
[edit]Legal status
[edit]Atacicept was approved for medical use in the United States in July 2026.[8] The FDA granted the application for atacicept priority review and breakthrough therapy designations. The approval of Trutakna was granted to Vera Therapeutics.[4]
Names
[edit]Atacicept is the international nonproprietary name.[9]
Atacicept is sold under the brand name Trutakna.[2]
References
[edit]- ↑ "Trutakna- atacicept injection, solution". DailyMed. 6 July 2026. Retrieved 20 July 2026.
- 1 2 3 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761486Orig1s000ltr.pdf
- ↑ "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.
- 1 2 3 4 5 6 7 8 9 "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. - ↑ 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.
- ↑ Stuart (14 January 2009). "Merck Serono and ZymoGenetics Initiate Atacicept Phase 2 Clinical Trial in Relapsing Multiple Sclerosis". Wellsphere. Archived from the original on 23 August 2010.
- ↑ 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.
External links
[edit]- Clinical trial number NCT04716231 for "Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)" at ClinicalTrials.gov
