| 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
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
Mechanism of action
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
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
Legal status
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
Atacicept is the international nonproprietary name.9
Atacicept is sold under the brand name Trutakna.2
References
References
- https://webfiles.veratx.com/docs/TRUTAKNA_Prescribing_Information.pdf
- 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.
- "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
External links
- Clinical trial number NCT04716231 for "Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)" at ClinicalTrials.gov