Drug Trials Snapshots

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Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.


Each Snapshot contains information about the drug in a question and answer format. At the end of each section of the Snapshot, there is a shaded bar with the words “MORE INFO”. Click the “MORE INFO” bar for more technical and detailed content. At the bottom of each Snapshot, there is a link to the drug’s Package Insert as well as the medical review.


The Snapshot is intended as one tool for consumers to use when discussing a drug’s risks and benefits with their physician. Do not rely on Snapshots alone to make decisions regarding medical care. Do not use Snapshots to substitute for advice from your health care professional.  Conclusions regarding how effective and safe a drug is among different sex, race, and age groups cannot always be made, often because the numbers of patients in some groups are too limited to allow for meaningful comparisons to other groups and to the overall results.


CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

DrugActive IngredientDate of FDA ApprovalWhat is it Approved ForPackage Insert
ADDYIflibanserinAugust 18, 2015Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal womenAddyi
ALECENSAalectinibDecember 11, 2015For the treatment of metastatic non-small cell lung cancerAlecensa
ANTHIMobiltoxaximabMarch 18, 2016For the treatment of inhalational anthraxANTHIM
ARISTADAaripiprazole laurixilOctober 5, 2015Treatment of schizophreniaAristada
AVYCAZ ceftazidime-avibactamFebruary 25, 2015Treatment of complicated intra-abdominal infection (abbreviated as cIAI) Avycaz
AVYCAZ ceftazidime-avibactamFebruary 25, 2015Treatment of complicated urinary tract infection (abbreviated as cUTI)Avycaz
AXUMINfluciclovine F 18May 27, 2016Detection of prostate cancer recurrenceAxumin
BRIDION sugammadex December 15, 2015  For the reversal of the effects of certain neuromuscular blocking agents Bridion 
BRIVIACT brivaracetam February 18, 2016  Treatment of partial-onset seizures Briviact 
CHOLBAM cholic acidMarch 17, 2015For treatment of bile acid synthesis disorders due to single enzyme defects Cholbam 
CHOLBAM cholic acidMarch 17, 2015For treatment of peroxisomal disorders, including Zellweger spectrum disorders Cholbam
CINQUAIR reslizumabMarch 23, 2016For the treatment of a specific type of severe asthma (called eosinophilic phenotype asthma)Cinquair
CORLANOR ivabradineApril 15, 2015To reduce hospitalization from worsening heart failure.Corlanor
COSENTYXsecukinumabJanuary 21, 2015Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skinCosentyx
COTELLIC(cobimetinib)November 10, 2015Part of combination treatment melanomaCotellic
CRESEMBAisavuconazonium sulfateMarch 6, 2015Treatment of invasive aspergillosisCresemba
CRESEMBAisavuconazonium sulfateMarch 6, 2015Treatment of invasive mucormycosisCresemba
DAKLINZAdaclatasvirJuly 24, 2015Treatment of chronic Hepatitis C genotype 3 infectionDaklinza
DALVANCEdalbavancin hydrochlorideMay 23, 2014Treatment of serious bacterial skin infectionsDalvance
DARZALEXdaratumumabNovember 16, 2015Treatment of multiple myelomaDarzalex
DEFITELIOdefibrotide sodiumMarch 30, 2016Treatment of hepatic veno-occlusive disease (VOD)Defitelio
EMPLICITIelotuzumabNovember 30, 2015Treatment of multiple myelomaEmpliciti
ENTRESTOsecubitril/valsartanJuly 7, 2015Treatment of heart failureEntresto 
ENTYVIOvedolizumabMay 20, 2014Treatment of Crohn’s DiseaseEntyvio
ENTYVIOvedolizumabMay 20, 2014Treatment of Ulcerative ColitisEntyvio
EPCLUSAsofosbuvir and velpatasvirJune 28, 2016Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection.Epclusa
EXONDYS 51eteplirsenSeptember 19, 2016 Treatment of particular type of Duchenne muscular dystrophy Exondys 51
FARYDAKpanobinostatFebruary 23, 2015Treatment of multiple myelomaFarydak
GENVOYAelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideNovember 5, 2015Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older.Genvoya
IBRANCEpalbociclibFebruary 3, 2015Treatment of a specific form of advanced breast cancer called ER-positive, HER2-negative (ER+/HER-) breast cancer in women who have gone through menopause (post-menopausal)Ibrance
JUBLIAefinaconazoleJune 6, 2014Treatment of fungal infection of the toenails due to two common forms of fungiJublia
KANUMAsebelipase alfaDecember 8, 2015Treatment of Lysosomal Acid Lipase (LAL) deficiencyKanuma
KENGREALcangrelorJune 22, 2015For prevention of coronary artery blood clot formation in patients undergoing PCIKengreal
KYBELLAdeoxycholic acidApril 29, 2015Treatment for double chinKybella
LENVIMAlenvatinibFebruary 13, 2015Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine Lenvima
LONSURFtrifluridine and tipiracilSeptember 22, 2015Treatment of advanced colorectal cancerLonsurf
NATPARAparathyroid hormoneJanuary 25, 2015For control of hypocalcemia along with calcium and vitamin D in adults with hypoparathyroidismNatpara
NETSPOTkit for the preparation of gallium Ga 68 dotatate injectionJune 1, 2016For detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs)Netspot
NINLAROixazomib November 20, 2015 Treatment of multiple myeloma Ninlaro 
NUCALAmepolizumabNovember 4, 2015For the treatment of a specific type of severe asthma (called eosinophilic phenotype asthma)Nucala
NUPLAZIDpimavanserinApril 29, 2016Treatment of hallucinations and delusions in patients with Parkinson’s diseaseNuplazid
OCALIVAobeticholic acidMay 27, 2016Treatment of primary biliary cholangitis in adultsOcaliva
ODOMZO sonidegibJuly 24, 2015Treatment of locally advanced basal cell carcinoma Odomzo
ORKAMBIlumacaftor/ivacaftorJuly 2, 2015Treatment of cystic fibrosisOrkambi
PORTRAZZAnecitumumabNovember 24, 2015For the treatment of metastatic squamous non-small cell lung cancerPortrazza
PRALUENT alirocumabJuly 24, 2015Treatment of certain patients with high cholesterol Praluent 
PRAXBINDidarucizumabOctober 16, 2015Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects.Praxbind
REPATHAevolocumabAugust 27, 2015Treatment of certain patients with high cholesterolRepatha
REXULTIbrexpiprazoleJuly 10, 2015Treatment of major depressive disorderRexulti 
REXULTIbrexpiprazoleJuly 10, 2015Treatment of schizophreniaRexulti
RYZODEGinsulin degludec and insulin aspart injectionSeptember 26, 2015Improves blood sugar control in adults with diabetes mellitus (DM)Ryzodeg
SAVAYSAedoxabanJanuary 8, 2015 Prevention of stroke in patients with atrial fibrillationSavaysa  
SAVAYSAedoxabanJanuary 8, 2015Reduction of risk of venous thromboembolism (VTE) in patients with previous VTESavaysa
SIVEXTROtedizolidJune 20, 2014Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infectionsSivextro
STIOLTO RESPIMATtiotropium bromide and olodaterolMay 21, 2015Long-term treatment of COPDStiolto Respimat
STRENSIQasfotase alfa October 23, 2015 Treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP) Strensiq 
TAGRISSOosimertinib December 3, 2015Treatment of patients with advanced non-small cell lung cancer (NSCLC)  Tagrisso 
TALTZixekizumabMarch 22, 2016Treatment of moderate to severe plaque psoriasis in adultsTaltz
TECENTRIQatezolizumabMay 18, 2016Treatment of a type of bladder cancer called urothelial carcinomaTecentriq
TRESIBAinsulin degludec injection September 26, 2015 To improve glucose control in adults with diabetes mellitus Tresiba 
UNITUXIN dinutuximabMarch 10, 2015Treatment of children with high-risk neuroblastomaUnituxin
UPTRAVIselexipagDecember 21, 2015For the treatment of adults with pulmonary artery hypertensionUptravi
VARUBIrolapitantSeptember 1, 2015To prevent delayed phase chemotherapy-induced nausea and vomitingVarubi
VELTASSApatiromerOctober 21, 2015Treatment of hyperkalemiaVeltassa
VENCLEXTAvenetoclaxApril 11, 2016Treatment of chronic lymphocytic leukemia (CLL)Venclexta
VIBERZIeluxadolineMay 27, 2015Treatment of irritable bowel syndrome with diarrheaViberzi
VISTOGARDuridine triacetateDecember 11, 2015For the  emergency treatment of an overdose with fluorouracil or capecitabineVistogard
VRAYLARcariprazineSeptember 17, 2015Treatment of bipolar disorderVraylar
VRAYLARcariprazineSeptember 17, 2015Treatment of schizophreniaVraylar
XURIDENuridine triacetateSeptember 4, 2015Treatment of patients with hereditary orotic aciduriaXuriden
YONDELIS trabectedin October 23, 2015 Treatment of certain types of advances tissue sarcoma  Yondelis 
ZEPATIERelbasvir and grazoprevirJanuary 28, 2016Treatment of chronic Hepatis C genotypes 1 or 4 infectionZepatier
ZINBRYTAdaclizumabMay 27, 2016Treatment of relapsing forms of multiple sclerosis (MS)Zinbryta
ZONTIVITYvorapaxarMay 8, 2014Reduction of heart attacks and stroke in high-risk patientsZontivity
ZURAMPIClesinuradDecember 22, 2015For lowering uric acid levels in the blood of adult patients with goutZurampic 

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Page Last Updated: 10/18/2016
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