Mr. Ibrahem/Berotralstat
Clinical data
Trade namesOrladeyo
Other namesBCX7353, BCX-7353
AHFS/Drugs.comMonograph
License data
Routes of
administration
By mouth
Drug classPlasma kallikrein inhibitor
Legal status
Legal status
Identifiers
  • 2-[3-(aminomethyl)phenyl]-N-[5-[(R)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide
Chemical and physical data
FormulaC30H26F4N6O
Molar mass562.573 g·mol−1
3D model (JSmol)
  • NCC1=CC(=CC=C1)N1N=C(C=C1C(=O)NC1=CC(=CC=C1F)[C@H](NCC1CC1)C1=CC=CC(=C1)C#N)C(F)(F)F
  • InChI=1S/C30H26F4N6O/c31-24-10-9-22(28(37-17-18-7-8-18)21-5-1-3-19(11-21)15-35)13-25(24)38-29(41)26-14-27(30(32,33)34)39-40(26)23-6-2-4-20(12-23)16-36/h1-6,9-14,18,28,37H,7-8,16-17,36H2,(H,38,41)/t28-/m1/s1
  • Key:UXNXMBYCBRBRFD-MUUNZHRXSA-N

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

Common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn.[2] Other side effects may include QT prolongation.[2] While there is no evidence of harm in pregnancy, such use has not been well studied.[2] It is a plasma kallikrein inhibitor.[2]

Berotralstat was approved for medical use in the United States in 2020 and Europe in 2021.[2][4] In the United Kingdom 4 weeks costs the NHS about £10,200 as of 2022.[5] This amount in the United States costs about 40,500 USD.[6]

References

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  1. ^ https://pdf.hres.ca/dpd_pm/00066149.PDF Archived 1 October 2022 at the Wayback Machine [bare URL PDF]
  2. ^ a b c d e f g h i j k l "Orladeyo- berotralstat hydrochloride capsule". DailyMed. Archived from the original on 1 November 2022. Retrieved 25 December 2020.
  3. ^ "Drug Trials Snapshot: Orladeyo". U.S. Food and Drug Administration. 3 December 2020. Archived from the original on 24 October 2021. Retrieved 25 December 2020.   This article incorporates text from this source, which is in the public domain.
  4. ^ a b "Orladeyo EPAR". European Medicines Agency (EMA). 24 February 2021. Archived from the original on 12 July 2021. Retrieved 12 July 2021.
  5. ^ "Berotralstat". SPS - Specialist Pharmacy Service. 21 July 2018. Archived from the original on 12 December 2021. Retrieved 3 November 2022.
  6. ^ "Orladeyo Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 21 May 2022. Retrieved 3 November 2022.