Drug Trials Snapshots
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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.Drug Trials
| Brand Name (Drug Trials Snapshot) | Drug Name | Original Date of FDA Approval | FDA Approved Use on Original Approval Date* | Brand Name (Prescribing Information) |
|---|---|---|---|---|
| WAYRILZ | rilzabrutinib | 8/29/2025 | To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids | Wayrilz |
| LEROCHOL | lerodalcibep-liga | 12/12/2025 | To reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause. | Lerochol |
| REDEMPLO | plozasiran | 11/18/2025 | To reduce triglycerides in adults with familial chylomicronemia syndrome | Redemplo |
| KYGEVVI | doxecitine and doxribtimine | 11/3/2025 | To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger | Kygevvi |
| LYNKUET | elinzanetant | 10/24/2025 | To reduce moderate to severe hot flashes due to menopause | Lynkuet |
| VIZZ | aceclidine ophthalmic solution | 7/31/2005 | For the treatment of presbyopia in adults. | Vizz |
| RHAPSIDO | remibrutinib | 9/30/2025 | To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment | Rhapsido |
| HERNEXEOS | zongertinib | 8/8/2025 | To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer | Hernexeos |
| DAWNZERA | donidalorsen | 8/21/2025 | To treat prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients | Dawnzera |
| LYNOZYFIC | linvoseltamab-gcpt | 7/2/2025 | To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody | Lynozyfic |
| BRINSUPRI | brensocatib | 8/12/2025 | To treat non-cystic fibrosis bronchiectasis | Brinsupri |
| ZEGFROVY | sunvozertinib | 7/2/2025 | For use as a single agent for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations | Zegfrovy |
| MODEYSO | dordaviprone | 08/06/2025 | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy | Modeyso |
| SEPHIENCE | sepiapterin | 07/28/2025 | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet | Sephience |
| ANZUPGO | delgocitinib | 07/23/2025 | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response | Anzupgo |
| EKTERLY | sebetralstat | 7/3/2025 | To treat acute attacks of hereditary angioedema | Ekterly |
| ANDEMBRY | garadacimab | 6/17/2025 | To prevent attacks of hereditary angioedema | Andemry |
| IBTROZI | taletrectinib | 6/11/2025 | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | Ibtrozi |
| ENFLONSIA | clesrovimab | 6/9/2025 | To treat respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants | Enflonsia |
| EMRELIS | telisotuzumab vedotin-tllv | 5/14/2025 | To treat adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer | Emrelis |
| TRYPTYR | acoltremon | 5/28/2025 | To treat the signs and symptoms of dry eye disease | Tryptyr |
| IMAAVY | nipocalimab-aahu | 4/29/2025 | To treat generalized myasthenia gravis | Imaavy |
| AVMAPKI FAKZYNJA CO-PACK | avutometinib; defactinib | 4/28/2025 | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | Avmapki Fakzynja Co-Pack |
| PENPULIMAB-KCQX | penpulimab-kcqx | 4/23/2025 | To treat adult patients with metastatic or recurrent, locally advanced non-keratinizing nasopharyngeal cancer | penpulimab-kcqx |
| VANRAFIA | atrasentan | 4/2/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Vanrafia |
| QFITLIA | fitusiran | 3/28/2025 | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B | Qfitlia |
| BLUJEPA | gepotidacin | 3/25/2025 | For the treatment of female adult and pediatric patients 12 years of age and older | Blujepa |
| ROMVIMZA | vimseltinib | 2/17/2025 | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity | Romvimza |
| GOMEKLI | mirdametinib | 2/11/2025 | For treatment in adults and children 2 years of age and older with neurofibromatosis type 1 (NF1) | Gomekli |
| JOURNAVX | suzetrigine | 1/30/2025 | For the treatment of moderate to severe acute pain in adults | Journavx |
| GRAFAPEX | treosulfan | 1/21/2025 | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients | Grafapex |
| ALYFTREK | vanzacaftor/tezacaftor/deutivacaftor | 12/20/2024 | For the treatment of cystic fibrosis (CF) in patients 6 years of age and older | Alyftrek |
| ALHEMO | concizumab | 12/20/2024 | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B | Alhemo |
| IOMERVU | iomeprol | 11/27/2024 | Is used during an arteriogram to visualize blood vessels in adult and pediatric patients | Iomervu |
| RAPIBLYK | landiolol hydrochloride | 11/22/2024 | For short-term reduction of ventricular rate in adults with supraventricular tachycardia. | Rapiblyk |
| 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 |
| BIZENGRI | zenocutuzumab-zbco | 12/4/2024 | To treat non-small cell lung cancer and pancreatic adenocarcinoma | Bizengri |
| 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 |
| CRENESSITY | crinecerfont | 12/13/2024 | To treat classic congenital adrenal hyperplasia | Crenessity |
| DATROWAY | datopotamab deruxtecan-dlnk | 1/17/2025 | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease | Datroway |
| 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 |
| ENSACOVE | ensartinib | 12/18/2024 | To treat non-small cell lung cancer | Ensacove |
| 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 |
| UNLOXCYT | cosibelimab-ipdl | 12/13/2024 | To treat cutaneous squamous cell carcinoma | Unloxcyt |
| 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.
Related Information
- FDA Basics Webinar - 4/27/2015: Drug Trials Snapshots
- New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products