Drug Trials Snapshots

Download 2023 Drug Trials Snapshots Summary Report
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Download 2022 Drug Trials Snapshots Summary Report

Download 2021 Drug Trials Snapshots Summary Report

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 Name	Original Date of FDA Approval	FDA Approved Use on Original Approval Date*	Brand Name (Prescribing Information)
TRYNGOLZA	olezarsen	12/19/2024	To treat familial chylomicronemia syndrome	Tryngolza
COBENFY	xanomeline tartrate and trospium chloride	9/26/2024	To treat schizophrenia	Cobenfy
ATTRUBY	acoramidis	11/22/2024	To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis	Attruby
ITOVEBI	inavolisib	10/10/2024	To treat locally advanced or metastatic breast cancer	Itovebi
HYMPAVZI	marstacimab	10/11/2024	To prevent or reduce bleeding episodes related to hemophilia A or B	Hympavzi
LAZCLUZE	lazertinib	8/19/2024	To treat non-small cell lung cancer	Lazcluze
MIPLYFFA	arimoclomol	9/20/2024	To treat Niemann-Pick disease type C	Miplyffa
AQNEURSA	levacetylleucine	9/24/2024	Treatment of Niemann-Pick disease type C	Aqneursa
NIKTIMVO	axatilimab-csfr	8/14/2024	To treat chronic graft-versus-host disease (cGVHD)	Niktimvo
EBGLYSS	lebrikizumab-lbkz	9/13/2024	An interleukin-13 antagonist indicated for the treatment of adult and pediatric patients 12 years of age and older	Ebglyss
LUMISIGHT	pegulicianine	4/17/2024	To use as an optical imaging agent for the detection of cancerous tissue	Lumisight
MIEBO	perfluorohexyloctane ophthalmic solution	5/18/2023	Treatment for patients with the signs and symptoms of dry eye disease (DED)	Miebo
AGAMREE	vamorolone	10/26/2023	Treatment of Duchenne muscular dystrophy	Agamree
AMVUTTRA	vutrisiran	6/13/2022	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis	Amvuttra
ANKTIVA	nogapendekin alfa inbakicept-pmnl	4/22/2024	To treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS)	Anktivia
APHEXDA	motixafortide	9/8/2023	To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma	Aphexda
AUGTYRO	repotrectinib	11/15/2023	To treat ROS1-positive non-small cell lung cancer	Augtyro
BEYFORTUS	nirsevimab	7/17/2023	Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease.	Beyfortus
BIMZELX	bimekizumab-bkzx	10/17/2023	Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.	Bimzelx
BRENZAVVY	bexagliflozin	1/20/2023	To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise	Brenzavvy
BRIUMVI	ublituximab-xiiy	12/28/2022	To treat relapsing forms of multiple sclerosis	Briumvi
CAMZYOS	mavacamten	4/28/2022	To treat certain classes of obstructive hypertrophic cardiomyopathy	Camzyos
CIBINQO	abrocitinib	1/14/2022	Treatment of adults with refractory, moderate-to-severe atopic dermatitis	Cibinqo
COLUMVI	glofitamab-gxbm	6/15/2023	Treatment 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 therapy	Columvi
DAXXIFY	daxibotulinumtoxin A	9/7/2022	To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity.	Daxxify
DAYBUE	trofinetide	3/12/2023	To treat Rett syndrome.	Daybue
DEFENCATH	taurolidine, heparin	11/15/2023	To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.	Defencath
DUVYZAT	givinostat	3/21/2024	Treatment of Duchenne muscular dystrophy in individuals aged 6 years and older	Duvyzat
ELAHERE	mirvetuximab soravtansine-gynx	11/14/2022	To treat patients with recurrent ovarian cancer that is resistant to platinum therapy	Elahere
ELFABRIO	pegunigalsidase alfa-iwx	5/9/2023	An enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients.	Elfabrio
ELREXFIO	elranatamab-bcmm	8/14/2023	To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy	Elrexfio
ELUCIREM	gadopiclenol	9/21/2022	To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body	Elucirem
ENJAYMO	sutimlimab-jome	2/4/2022	To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease	Enjaymo
EPKINLY	epcoritamab-bysp	5/19/2023	To 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 therapy	Epkinly
EXBLIFEP	cefepime and enmetazobactam	2/22/2024	For the treatment of patients 18 years and older with complicated urinary tract infections (cUTI)	Exblifep
EXXUA	gepirone	9/22/2023	Treatment of major depressive disorder	Exxua
FABHLATA	iptacopan	12/5/2023	Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)	Fabhlata
FILSPARI	sparsentan	2/17/2023	To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression	Filspari
FILSUVEZ	birch triterpenes	12/18/2023	To treat wounds associated with dystrophic and junctional epidermolysis bullosa	Filsuvez
FLYRCADO	flurpiridaz F 18 Injection	9/27/2024	A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction	Flyrcado
FRUZAQLA	fruquintinib	11/8/2023	To treat refractory, metastatic colorectal cancer	Fruzaqla
IMJUDO	tremelimimab-actl	10/21/2022	To treat unresectable hepatocellular carcinoma	Imjudo
INPEFA	sotagliflozin	5/26/2023	Treatment of heart failure	Inpefa
IQIRVO	elafibranor	6/10/2024	To 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	iqirvo
IZERVAY	avacincaptad pegol intravitreal solution	8/4/2023	To treat geographic atrophy secondary to age-related macular degeneration	Izervay
JAYPIRCA	pirtobrutinib	1/27/2023	To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor	Jaypirca
JOENJA	leniolisib	3/24/2023	Treatment of activated phosphoinositide 3-kinase delta syndrome.	Joenja
JESDUVROQ	daprodustat	2/1/2023	Treatment of anemia caused by chronic kidney disease for adults on dialysis for at least four months.	Jesduvroq
KIMMTRAK	tebentafusp	1/25/2022	To treat unresectable or metastatic uveal melanoma	Kimmtrak
KISUNLA	donanemab-azbt	7/2/2024	To treat people with Alzheimer’s disease	Kisunla
KRAZATI	adagrasib	12/12/2022	Prescription medicine used to treat adult patients with non-small cell lung cancer	Krazati
LAMZEDE	velmanase alfa-tycv	2/16/2023	To treat non-central nervous system manifestations of alpha-mannosidosis	Lamzede
LEQEMBI	lecanemab-irmb	1/6/2023	Treatment of Alzheimer’s disease	Leqembi
LEQSELVI	deuruxolitinib	7/25/2024	Indicated for the treatment of adults with severe alopecia areata (AA).	Leqselvi
LETYBO	letibotulinumtoxinA	2/29/2024	To temporarily improve the appearance of moderate-to-severe glabellar lines	Letybo
LIVDELZI	seladelpar	8/14/2024	To 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
LUNSUMIO	mosunetuzumab-axgb	12/22/2022	To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma	Lunsumio
LYTGOBI	futibatinib	9/30/2022	To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements	Lytgobi
MOUNJARO	tirzepatide	5/13/2022	To improve blood sugar control in diabetes, in addition to diet and exercise	Mounjaro
NEMLUVIO	nemolizumab-ilto	8/12/2024	To treat prurigo nodularis	Nemluvio
NEXOBRID	anacaulase-bcdb	12/28/2022	To remove charred tissue in adults with deep second degree and/or third degree burns from heat sources	Nexobrid
NGENLA	somatrogon-ghla	6/27/2023	Treatment of growth failure due to inadequate secretion of endogenous growth hormone	Ngenla
OGSIVEO	nirogacestat	11/27/2023	To treat adults with progressing desmoid tumors who require systemic treatment	Ogsiveo
OHTUVAYRE	ensifentrine	6/26/2024	For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.	Ohtuvayre
OJEMDA	tovorafenib	4/23/2024	To treat certain types of brain tumors (cancers) called gliomas in patients 6 months and older	Ojemda
OJJAARA	momelotinib	9/15/2023	to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemia	Ojjaara
OMLONTI	oomidenepag isopropyl	9/22/2022	Reduces elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension	Omlonti
OPDUALAG	nivolumab and relatlimab-rmbw	3/18/2022	Treatment 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
ORLYNVAH	sulopenem etzadroxil and probenecid	10/25/2024	Treatment of uncomplicated urinary tract infections (uUTI)	Orlynvah
ORSERDU	elacestrant	1/27/2023	To 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
PAXLOVID	nirmatrelvir, ritonavir	5/25/2023	To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19	Paxlovid
PIASKY	crovalimab-akkz	6/20/2024	Treatment of paroxysmal nocturnal hemoglobinuria	Piasky
PLUVICTO	lutetium Lu 177 vipivotide tetraxetan	3/23/2022	To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies	Pluvicto
POMBILITI	cipaglucosidase alfa-atga	9/28/2023	the treatment of adult patients with late-onset Pompe disease (LOPD)	Pombiliti Opfolda
POSLUMA	flotufolastat F 18	5/25/2023	To detect specific cancer lesions in males with prostate cancer	Posluma
PYRUKYND	mitapivat	2/17/2022	Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency	Pyrukynd
QALSODY	tofersen	4/25/2023	Treatment of amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation	Qalsody
QUVIVIQ	daridorexant	1/7/2022	Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.	Quvivq
RELYVRIO	sodium phenylbutyrate and taurursodiol	9/29/2022	To treat amyotrophic lateral sclerosis (ALS)	Relyvrio
REVUFORJ	revumenib	11/15/2024	To treat relapsed or refractory acute leukemia	Revuforj
REZDIFFRA	resmetirom	3/14/2024	To treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.	Rezdiffra
REZLIDHIA	olutasidenib	12/1/2022	Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation	Rezlidhia
ZAYO	rezafungin for injection	3/22/2023	To treat candidemia and invasive candidiasis	Rezzayo
RIVFLOZA	nedosiran	9/29/2023	To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function	Rivfloza
ROLVEDON	eflapegrastim	9/9/2022	To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia	Rolvedon
RYSTIGGO	rozanolixizumab-noli	6/26/2023	To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive	Rystiggo
RYTELO	imetelsta	6/6/2024	to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemia	Rytelo
RYZNEUTA	efbemalenograstim alfa-vuxw	11/11/2023	To treat neutropenia	Ryzneuta
SKYCLARYS	omaveloxolone	2/28/2023	To treat Friedrich’s ataxia	Skyclarys
SOFDRA	sofpironium bromide	6/18/2024	An anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.	Sofdra
SOHONOS	palovarotene	8/16/2023	To 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 progressiva	Sohonos
SOTYKTU	deucravacitinib	9/9/2022	To treat moderate-to-severe plaque psoriasis	Sotyktu
SPEVIGO	spesolimab-sbzo	9/1/2022	To treat generalized pustular psoriasis flares	Spevigo
SUNLENCA	lenacapavir	12/22/2022	To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations	Sunlenca
TALVEY	talquetamab-tgvs	8/10/2023	To treat a form of blood cancer called multiple myeloma	Talvey
TECVAYLI	teclistamab-cqyv	10/25/2022	To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy	Tecvayli
TERLIVAZ	terlipressin	9/14/2022	Treatment to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function	Terlivaz
TEVIMBRA	tislelizumab-jsgr	3/14/2024	To treat unresectable or metastatic esophageal squamous cell carcinoma	Tevimbra
TRUQAP	capivasertib	11/16/2023	To treat breast cancer that meets certain disease criteria	Truqap
TZIELD	teplizumab-mzwv	11/17/2022	Used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetes	Tzield
VABYSMO	faricimab-svoa	1/28/2022	To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema	Vabysmo
VAFSEO	vadadustat	3/27/2024	To treat anemia due to chronic kidney disease	Vafseo
VANFLYTA	quizartinib	7/20/2023	To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria	Vanflyta
VELSIPITY	etrasimod	10/12/2023	To treat moderately to severely active ulcerative colitis in adults	Velsipity
VEOPOZ	pozelimab-bbfg	8/18/2023	To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease	Veopoz
VEOZAH	fezolinetant	5/12/2023	To treat moderate to severe hot flashes caused by menopause	Veozah
VIVJOA	oteseconazole	4/26/2022	To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential	Vivjoa
VONJO	pacritinib	2/28/2022	To treat adult patients with a rare type of bone marrow disorder called myelofibrosis with platelet counts below 50,000/µL.	Vonjo
VOQUEZNA	vonoprazan fumarate, amoxicillin	5/3/2022	Treatment of Helicobacter pylori infection	Voquezna
VORANIGO	vorasidenib	8/6/2024	Treatment of Grade 2 astrocytoma or oligodendroglioma	Voranigo
VOYDEYA	danicopan	3/29/2024	To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria	Voydeya
VTAMA	tapinarof	12/7/2023	Treatment of plaque psoriasis	Vtama
VYLOY	zolbetuximab-clzb	10/18/2024	To treat gastric or gastroesophageal junction adenocarcinoma	Vyloy
WAINUA	eplontersen	12/21/2023	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis	Wainua
WINREVAIR	sotatercept-csrk	3/26/2024	For the treatment of adults with pulmonary arterial hypertension	Winrevair
XACDURO	sulbactam for injection; durlobactam for injection	5/23/2023	Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex	Xacduro
XDEMVY	lotilaner ophthalmic solution	7/24/2023	To treat Demodex blepharitis, a type of eyelid infection.	xdemvy
XENOVIEW	xenon Xe 129 hyperpolarized	12/8/2023	Evaluation of lung ventilation in adults and pediatric patients	Xenoview
XENPOZYME	olipudase alfa-rpcp	8/31/2023	To treat Acid Sphingomyelinase Deficiency	Xenpozyme
XOLREMDI	mavorixafor	4/26/2024	For the treatment of adults and adolescents over the age of 12 years with WHIM (Warts, Hypogammaglobulinemia, Infection, and Myelokathexis) syndrome	Xolremdi
YORVIPATH	palopegteriparatide	8/9/2024	To treat hypoparathyroidism	Yorvipath
ZAVZPRET	zavegepant	3/9/2023	To treat migraine	Zavzpret
ZELSUVMI	berdazimer	1/5/2024	Treatment of molluscum contagiosum	Zelsuvmi
ZEVTERA	ceftobiprole medocaril sodium for injection	4/3/2024	Treatment of certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia	Zevtera
ZIIHERA	zanidatamab-hrii	11/20/2024	To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer	Ziihera
ZILBRYSQ	zilucoplan	10/17/2023	To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive	Zilbrysq
ZTALMY	ganaxolone	3/18/2023	To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder	Ztalmy
ZURZUVAE	zuranolone	8/4/2023	To treat postpartum depression	Zurzuvae

^* 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.