berotralstat berotralstat berotralstat, sold under the brand name orladeyo, is a medication used to prevent attacks of hereditary angioedema (hae) in people aged twelve years and older. berotralstatclinical datatrade namesorladeyoother namesbcx7353, bcx-7353license data eu ema: by inn us dailymed: berotralstat routes ofadministrationby mouthdrug classplasma kallikrein inhibitoratc codeb06ac06 (who) legal statuslegal status ca: ℞-only us: ℞-only eu: rx-only identifiers iupac name 2--n--2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide cas number1809010-50-1as hcl: 1809010-52-3pubchem cid137528262drugbankdb15982chemspider81368516uniixza0kb1bdqas hcl: 88sh1nbl2bkeggd11673as hcl: d11674chemical and physical dataformulac30h26f4n6omolar mass562.573 g·mol−13d model (jsmol)interactive image smiles ncc1=cc(=cc=c1)n1n=c(c=c1c(=o)nc1=cc(=cc=c1f)(ncc1cc1)c1=cc=cc(=c1)c#n)c(f)(f)f inchi 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/s1key:uxnxmbycbrbrfd-muunzhrxsa-n the most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn. berotralstat was approved for medical use in the united states in december 2020, and in the european union in april 2021. history berotralstat was approved based on evidence from one clinical trial (trial 1 /nct03485911) of 120 participants with hereditary angioedema. the trial was conducted at 40 sites in the united states, the european union, and canada. trial investigators evaluated participants 12 years and older with hereditary angioedema for eight weeks to determine the number of attacks for each participant. the trial enrolled only participants who had at least two attacks during the eight-week period. participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks. neither the participants nor the investigators knew which treatment was being given until after the trial was completed. all participants could use other medications for treatment of attacks.