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  1. Drug Approvals and Databases

Drug Trials Snapshots

Contact Us at Snapshots@fda.hhs.gov

Drug Trials Snapshots at a Glance

Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in the key clinical trials that supported the original FDA approval of new drugs by FDA’s Center for Drug Evaluation and Research.

  • Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent.
  • The information in the Snapshots also highlights where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups (sex, race, age, and ethnicity).

How to Read Snapshots

Each Snapshot contains information about the drug in a question and answer format. Each Snapshot contains a “MORE INFO” section for more detailed and technical content.

  • Consumer information is presented first.
  • At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. This section is for anyone interested in additional information. Click the “MORE INFO” bar for more technical and detailed content including data.
  • At the beginning and at the end of each Snapshot, there is a link to the drug’s Prescribing Information (formerly known as the Package Insert).

Limitations of Snapshots

The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their healthcare provider. Do not rely on Snapshots alone to make decisions regarding medical care.

  • Snapshots are not a substitute for advice from your health care professional.
  • Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. Conclusions regarding these differences cannot always be made.

Frequently Asked Questions

Are all approved drugs presented in Snapshots?
No. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. NMEs and original biologics are medications made of new molecular structures that have not been approved by the FDA before. The Snapshots program began in 2015 and reflects drugs approved after that time.

Are individual Snapshots updated? 
No. The snapshots are published within 30 days of approval and contain information that was available at the time of approval.

Where can I send comments or questions about snapshots?
Comments and questions can be sent to: Snapshots@fda.hhs.gov.

Brand Name (Drug Trials Snapshot)Drug NameOriginal Date of FDA ApprovalFDA Approved Use on Original Approval Date*Brand Name (Prescribing Information)
TRYNGOLZAolezarsen12/19/2024To treat familial chylomicronemia syndromeTryngolza
COBENFYxanomeline tartrate and trospium chloride9/26/2024To treat schizophreniaCobenfy
ATTRUBYacoramidis11/22/2024To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosisAttruby
ITOVEBIinavolisib10/10/2024To treat locally advanced or metastatic breast cancerItovebi
HYMPAVZImarstacimab10/11/2024To prevent or reduce bleeding episodes related to hemophilia A or BHympavzi
LAZCLUZElazertinib8/19/2024To treat non-small cell lung cancerLazcluze
MIPLYFFAarimoclomol9/20/2024To treat Niemann-Pick disease type CMiplyffa
AQNEURSAlevacetylleucine9/24/2024Treatment of Niemann-Pick disease type CAqneursa
NIKTIMVOaxatilimab-csfr8/14/2024To treat chronic graft-versus-host disease (cGVHD)Niktimvo
EBGLYSSlebrikizumab-lbkz9/13/2024An interleukin-13 antagonist indicated for the treatment of adult and pediatric patients 12 years of age and olderEbglyss
LUMISIGHTpegulicianine4/17/2024To use as an optical imaging agent for the detection of cancerous tissueLumisight
MIEBOperfluorohexyloctane ophthalmic solution5/18/2023Treatment for patients with the signs and symptoms of dry eye disease (DED)Miebo
AGAMREEvamorolone10/26/2023Treatment of Duchenne muscular dystrophyAgamree
AMVUTTRAvutrisiran6/13/2022To treat polyneuropathy of hereditary transthyretin-mediated amyloidosisAmvuttra
ANKTIVAnogapendekin alfa inbakicept-pmnl4/22/2024To treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS)Anktivia
APHEXDAmotixafortide9/8/2023To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myelomaAphexda
AUGTYROrepotrectinib11/15/2023To treat ROS1-positive non-small cell lung cancerAugtyro
BEYFORTUSnirsevimab7/17/2023Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease.Beyfortus
BIMZELXbimekizumab-bkzx10/17/2023Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.Bimzelx
BRENZAVVY bexagliflozin1/20/2023To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exerciseBrenzavvy
BRIUMVIublituximab-xiiy12/28/2022To treat relapsing forms of multiple sclerosisBriumvi
CAMZYOSmavacamten4/28/2022To treat certain classes of obstructive hypertrophic cardiomyopathyCamzyos
CIBINQOabrocitinib1/14/2022Treatment of adults with refractory, moderate-to-severe atopic dermatitisCibinqo
COLUMVIglofitamab-gxbm6/15/2023Treatment of diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapyColumvi
DAXXIFYdaxibotulinumtoxin A9/7/2022To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity.Daxxify
DAYBUEtrofinetide3/12/2023To treat Rett syndrome.Daybue
DEFENCATHtaurolidine, heparin11/15/2023To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.Defencath
DUVYZATgivinostat3/21/2024Treatment of Duchenne muscular dystrophy in individuals aged 6 years and olderDuvyzat
ELAHEREmirvetuximab soravtansine-gynx11/14/2022To treat patients with recurrent ovarian cancer that is resistant to platinum therapyElahere
ELFABRIOpegunigalsidase alfa-iwx5/9/2023An enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients.Elfabrio
ELREXFIOelranatamab-bcmm8/14/2023To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapyElrexfio
ELUCIREMgadopiclenol9/21/2022To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the bodyElucirem
ENJAYMOsutimlimab-jome2/4/2022To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin diseaseEnjaymo
EPKINLYepcoritamab-bysp5/19/2023To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapyEpkinly
EXBLIFEPcefepime and enmetazobactam2/22/2024For the treatment of patients 18 years and older with complicated urinary tract infections (cUTI)Exblifep
EXXUAgepirone9/22/2023Treatment of major depressive disorderExxua
FABHLATAiptacopan12/5/2023Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)Fabhlata
FILSPARIsparsentan2/17/2023To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionFilspari
FILSUVEZbirch triterpenes12/18/2023To treat wounds associated with dystrophic and junctional epidermolysis bullosaFilsuvez
FLYRCADOflurpiridaz F 18 Injection9/27/2024A radioactive diagnostic drug to evaluate for myocardial ischemia and infarctionFlyrcado
FRUZAQLAfruquintinib11/8/2023To treat refractory, metastatic colorectal cancerFruzaqla
IMJUDOtremelimimab-actl10/21/2022To treat unresectable hepatocellular carcinomaImjudo
INPEFAsotagliflozin5/26/2023Treatment of heart failureInpefa
IQIRVOelafibranor6/10/2024To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCAiqirvo
IZERVAYavacincaptad pegol intravitreal solution8/4/2023To treat geographic atrophy secondary to age-related macular degenerationIzervay
JAYPIRCApirtobrutinib1/27/2023To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitorJaypirca
JOENJAleniolisib3/24/2023Treatment of activated phosphoinositide 3-kinase delta syndrome.Joenja
JESDUVROQdaprodustat2/1/2023Treatment of anemia caused by chronic kidney disease for adults on dialysis for at least four months.Jesduvroq
KIMMTRAKtebentafusp1/25/2022To treat unresectable or metastatic uveal melanomaKimmtrak
KISUNLAdonanemab-azbt7/2/2024To treat people with Alzheimer’s diseaseKisunla
KRAZATIadagrasib12/12/2022Prescription medicine used to treat adult patients with non-small cell lung cancerKrazati
LAMZEDEvelmanase alfa-tycv2/16/2023To treat non-central nervous system manifestations of alpha-mannosidosisLamzede
LEQEMBIlecanemab-irmb1/6/2023Treatment of Alzheimer’s diseaseLeqembi
LEQSELVIdeuruxolitinib7/25/2024Indicated for the treatment of adults with severe alopecia areata (AA).Leqselvi
LETYBOletibotulinumtoxinA2/29/2024To temporarily improve the appearance of moderate-to-severe glabellar linesLetybo
LIVDELZIseladelpar8/14/2024To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.Livdelzi
LUNSUMIOmosunetuzumab-axgb12/22/2022To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphomaLunsumio
LYTGOBIfutibatinib9/30/2022To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangementsLytgobi
MOUNJAROtirzepatide5/13/2022To improve blood sugar control in diabetes, in addition to diet and exerciseMounjaro
NEMLUVIOnemolizumab-ilto8/12/2024To treat prurigo nodularisNemluvio
NEXOBRIDanacaulase-bcdb12/28/2022To remove charred tissue in adults with deep second degree and/or third degree burns from heat sourcesNexobrid
NGENLAsomatrogon-ghla6/27/2023Treatment of growth failure due to inadequate secretion of endogenous growth hormoneNgenla
OGSIVEOnirogacestat11/27/2023To treat adults with progressing desmoid tumors who require systemic treatmentOgsiveo
OHTUVAYREensifentrine6/26/2024For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.Ohtuvayre
OJEMDAtovorafenib4/23/2024To treat certain types of brain tumors (cancers) called gliomas in patients 6 months and olderOjemda
OJJAARAmomelotinib9/15/2023to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemiaOjjaara
OMLONTIoomidenepag isopropyl9/22/2022Reduces elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertensionOmlonti
OPDUALAGnivolumab and relatlimab-rmbw3/18/2022Treatment of adults and pediatric patients 12 years of age or older with a type of skin cancer called melanoma that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic).Opdualag
ORLYNVAHsulopenem etzadroxil and probenecid10/25/2024Treatment of uncomplicated urinary tract infections (uUTI)Orlynvah
ORSERDUelacestrant1/27/2023To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.Orserdu
PAXLOVIDnirmatrelvir, ritonavir5/25/2023To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19Paxlovid
PIASKYcrovalimab-akkz6/20/2024Treatment of paroxysmal nocturnal hemoglobinuriaPiasky
PLUVICTOlutetium Lu 177 vipivotide tetraxetan3/23/2022To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapiesPluvicto
POMBILITIcipaglucosidase alfa-atga9/28/2023the treatment of adult patients with late-onset Pompe disease (LOPD)Pombiliti
Opfolda
POSLUMAflotufolastat F 185/25/2023To detect specific cancer lesions in males with prostate cancerPosluma
PYRUKYNDmitapivat2/17/2022Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiencyPyrukynd
QALSODYtofersen4/25/2023Treatment of amyotrophic lateral sclerosis in adults who have a SOD1 gene mutationQalsody
QUVIVIQdaridorexant1/7/2022Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.Quvivq
RELYVRIOsodium phenylbutyrate and taurursodiol9/29/2022To treat amyotrophic lateral sclerosis (ALS)Relyvrio
REVUFORJ 
 
revumenib11/15/2024To treat relapsed or refractory acute leukemiaRevuforj
REZDIFFRAresmetirom3/14/2024To treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.Rezdiffra
REZLIDHIAolutasidenib12/1/2022Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutationRezlidhia
ZAYOrezafungin for injection3/22/2023To treat candidemia and invasive candidiasisRezzayo
RIVFLOZAnedosiran9/29/2023To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney functionRivfloza
ROLVEDONeflapegrastim9/9/2022To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropeniaRolvedon
RYSTIGGOrozanolixizumab-noli6/26/2023To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positiveRystiggo
RYTELOimetelsta6/6/2024to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemiaRytelo
RYZNEUTAefbemalenograstim alfa-vuxw11/11/2023To treat neutropeniaRyzneuta
SKYCLARYSomaveloxolone2/28/2023To treat Friedrich’s ataxiaSkyclarys
SOFDRAsofpironium bromide6/18/2024An anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.Sofdra
SOHONOSpalovarotene8/16/2023To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressivaSohonos
SOTYKTUdeucravacitinib9/9/2022To treat moderate-to-severe plaque psoriasisSotyktu
SPEVIGOspesolimab-sbzo9/1/2022To treat generalized pustular psoriasis flaresSpevigo
SUNLENCAlenacapavir12/22/2022To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerationsSunlenca
TALVEYtalquetamab-tgvs8/10/2023To treat a form of blood cancer called multiple myelomaTalvey
TECVAYLI teclistamab-cqyv10/25/2022To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapyTecvayli
TERLIVAZterlipressin9/14/2022Treatment to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney functionTerlivaz
TEVIMBRAtislelizumab-jsgr3/14/2024To treat unresectable or metastatic esophageal squamous cell carcinomaTevimbra
TRUQAPcapivasertib11/16/2023To treat breast cancer that meets certain disease criteriaTruqap
TZIELDteplizumab-mzwv11/17/2022Used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetesTzield
VABYSMOfaricimab-svoa1/28/2022To treat neovascular (wet) aged-related macular degeneration and diabetic macular edemaVabysmo
VAFSEOvadadustat3/27/2024To treat anemia due to chronic kidney diseaseVafseo
VANFLYTAquizartinib7/20/2023To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteriaVanflyta
VELSIPITYetrasimod10/12/2023To treat moderately to severely active ulcerative colitis in adultsVelsipity
VEOPOZpozelimab-bbfg8/18/2023To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE diseaseVeopoz
VEOZAHfezolinetant5/12/2023To treat moderate to severe hot flashes caused by menopauseVeozah
VIVJOAoteseconazole4/26/2022To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potentialVivjoa
VONJOpacritinib2/28/2022To treat adult patients with a rare type of bone marrow disorder called myelofibrosis with platelet counts below 50,000/µL.Vonjo
VOQUEZNAvonoprazan fumarate, amoxicillin5/3/2022Treatment of Helicobacter pylori infectionVoquezna
VORANIGOvorasidenib8/6/2024Treatment of Grade 2 astrocytoma or oligodendrogliomaVoranigo
VOYDEYAdanicopan3/29/2024To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuriaVoydeya
VTAMAtapinarof12/7/2023Treatment of plaque psoriasisVtama
VYLOYzolbetuximab-clzb10/18/2024To treat gastric or gastroesophageal junction adenocarcinomaVyloy
WAINUAeplontersen12/21/2023To treat polyneuropathy of hereditary transthyretin-mediated amyloidosisWainua
WINREVAIRsotatercept-csrk3/26/2024For the treatment of adults with pulmonary arterial hypertensionWinrevair
XACDUROsulbactam for injection; durlobactam for injection5/23/2023Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complexXacduro
XDEMVYlotilaner ophthalmic solution7/24/2023To treat Demodex blepharitis, a type of eyelid infection. xdemvy
XENOVIEWxenon Xe 129 hyperpolarized12/8/2023Evaluation of lung ventilation in adults and pediatric patientsXenoview
XENPOZYMEolipudase alfa-rpcp8/31/2023To treat Acid Sphingomyelinase DeficiencyXenpozyme
XOLREMDImavorixafor4/26/2024For the treatment of adults and adolescents over the age of 12 years with WHIM (Warts, Hypogammaglobulinemia, Infection, and Myelokathexis) syndromeXolremdi
YORVIPATHpalopegteriparatide8/9/2024To treat hypoparathyroidismYorvipath
ZAVZPRETzavegepant3/9/2023To treat migraineZavzpret
ZELSUVMIberdazimer1/5/2024Treatment of molluscum contagiosumZelsuvmi
ZEVTERAceftobiprole medocaril sodium for injection4/3/2024Treatment of certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumoniaZevtera
ZIIHERAzanidatamab-hrii11/20/2024To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancerZiihera
ZILBRYSQzilucoplan10/17/2023To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positiveZilbrysq
ZTALMYganaxolone3/18/2023To treat seizures in cyclin-dependent kinase-like 5 deficiency disorderZtalmy
ZURZUVAEzuranolone8/4/2023To treat postpartum depressionZurzuvae

* The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information.

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