Berotralstat

Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people twelve years and older.[3][4][2]

Berotralstat
Clinical data
Trade namesOrladeyo
Other namesBCX7353, BCX-7353
License data
Routes of
administration		By mouth
Drug classPlasma kallikrein inhibitor
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC30H26F4N6O
Molar mass562.573 g·mol−1
3D model (JSmol)

The most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn.[2]

Berotralstat was approved for medical use in the United States in December 2020.[2][5]

History

Berotralstat was approved based on evidence from one clinical trial (Trial 1 /NCT03485911) of 120 participants with hereditary angioedema.[2] The trial was conducted at 40 sites in the United States, the European Union, and Canada.[2] Trial investigators evaluated participants 12 years and older with hereditary angioedema for eight weeks to determine the number of attacks for each participant.[2] The trial enrolled only participants who had at least two attacks during the eight-week period.[2] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks.[2] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed.[2] All participants could use other medications for treatment of attacks.[2]

References
  1. "Orladeyo- berotralstat hydrochloride capsule". DailyMed. Retrieved 25 December 2020.
  2. "Drug Trials Snapshot: Orladeyo". U.S. Food and Drug Administration. 3 December 2020. Retrieved 25 December 2020. This article incorporates text from this source, which is in the public domain.
  3. Hwang JR, Hwang G, Johri A, Craig T (December 2019). "Oral plasma kallikrein inhibitor BCX7353 for treatment of hereditary angioedema". Immunotherapy. 11 (17): 1439–1444. doi:10.2217/imt-2019-0128. PMID 31635497.
  4. Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, et al. (October 2020). "Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial". The Journal of Allergy and Clinical Immunology. doi:10.1016/j.jaci.2020.10.015. PMID 33098856.
  5. "Orladeyo: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 December 2020.
  • "Berotralstat". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03485911 for "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)" at ClinicalTrials.gov
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