Who Was in the Trials
Before approving a new drug, FDA reviews the trials behind it. FDA's Drug Trials Snapshots say who took part: how many were women, older adults, or Black, Hispanic or Asian. This puts every snapshot side by side.
The participants behind 177 new drugs FDA approved from Jan 7, 2022 to May 27, 2026, from FDA's Drug Trials Snapshots, summed across each drug's main trials. 132 snapshots give the counts in a table.
- Snapshots, last 12 months: 33
- Median share of women: 47%
- Median share 65 and older: 24%
- Median share Black: 2%
- Approvals under 5% Black participants: 73%
Median Share by Group
Across approvals, percent of trial participants.
- Women4747%
- 65 and older2424%
- White7575%
- Black22%
- Hispanic or Latino77%
- Asian55%
Black Participants
Approvals by the share of Black participants in their trials.
- Under 2%67
- 2% to 5%28
- 5% to 10%13
- 10% to 15%11
- 15% or more11
Participants 65 and Older
Approvals by the share of participants 65 and older.
- Under 2%19
- 2% to 5%4
- 5% to 10%7
- 10% to 15%8
- 15% or more61
Every Snapshot
Sort any column to find the trials with the fewest women, older adults or Black participants.| May 27, 2026 | DECNUPAZpivekimab sunirine · for adults with blastic plasmacytoid dendritic cell neoplasm | 51 | 18% | 27% | 4% | 16% | 2% |
| Mar 17, 2026 | ICOTYDEicotrokinra · for moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy | 774 | 33% | 10% | 2% | 14% | 20% |
| Jan 12, 2026 | ZYCUBOcopper histidinate · for Menkes disease | 129 | 0% | — | <1% | <1% | 0% |
| Dec 23, 2025 | YARTEMLEAnarsoplimab · for hematopoietic stem cell transplant-associated thrombotic microangiopathy | 47 | 34% | 0% | 4% | 4% | 15% |
| Dec 19, 2025 | MYQORZOaficamten · for symptomatic obstructive hypertrophic cardiomyopathy | 282 | 41% | 29% | 1% | 3% | 0% |
| Dec 16, 2025 | EXDENSURdepemokimab · for severe asthma characterized by an eosinophilic phenotype as an add-on maintenance therapy | Not in a table | — | — | — | — | — |
| Dec 12, 2025 | NUZOLVENCEzoliflodacin · for uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae | 506 | 10% | <1% | 55% | 3% | 32% |
| Dec 12, 2025 | CARDAMYSTetripamil · for episodes of paroxysmal supraventricular tachycardia | 255 | 46% | — | 2% | 4% | 2% |
| Dec 12, 2025 | LEROCHOLlerodalcibep-liga · To reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause. | 922 | 20% | 31% | 11% | <1% | 2% |
| Nov 25, 2025 | VOYXACTsibeprenlimab-szsi · To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression | 320 | 38% | — | <1% | 12% | 59% |
| Nov 19, 2025 | HYRNUOsevabertinib · for locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy | 122 | 67% | 39% | 3% | 2% | 66% |
| Nov 18, 2025 | REDEMPLOplozasiran · To reduce triglycerides in adults with familial chylomicronemia syndrome | 26 | 54% | 15% | 0% | 0% | 27% |
| Nov 13, 2025 | KOMZIFTIziftomenib · for adult patients with acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation | 112 | 56% | 63% | 2% | 3% | 4% |
| Nov 3, 2025 | KYGEVVIdoxecitine and doxribtimine · for thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger | 78 | 46% | — | 4% | 36% | 5% |
| Oct 24, 2025 | LYNKUETelinzanetant · To reduce moderate to severe hot flashes due to menopause | 1,420 | — | 0% | 16% | 10% | <1% |
| Sep 30, 2025 | RHAPSIDOremibrutinib · for chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment | Not in a table | — | — | — | — | — |
| Sep 25, 2025 | INLURIYOimlunestrant · for estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy | Not in a table | — | — | — | — | — |
| Sep 19, 2025 | FORZINITYelamipretide · To improve muscle strength in patients with Barth syndrome weighing at least 30 kg | 12 | 0% | — | 0% | 0% | 0% |
| Aug 29, 2025 | WAYRILZrilzabrutinib · for persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids | 202 | 63% | — | <1% | 20% | 32% |
| Aug 21, 2025 | DAWNZERAdonidalorsen · for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients | 45 | 62% | 2% | 2% | 4% | 2% |
| Aug 12, 2025 | BRINSUPRIbrensocatib · for non-cystic fibrosis bronchiectasis | 665 | 66% | 49% | <1% | 27% | 10% |
| Aug 8, 2025 | HERNEXEOSzongertinib · for adults with unresectable or metastatic non-squamous non-small cell lung cancer | 105 | 69% | 10% | 0% | 2% | 49% |
| Aug 6, 2025 | MODEYSOdordaviprone · for diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy | 376 | 52% | 4% | 9% | 13% | 4% |
| Jul 31, 2025 | VIZZaceclidine ophthalmic solution · For the treatment of presbyopia in adults. | 698 | 65% | 0% | 5% | 25% | 5% |
| Jul 28, 2025 | SEPHIENCEsepiapterin · for hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet | 49 | 47% | — | 0% | 16% | 0% |
| Jul 23, 2025 | ANZUPGOdelgocitinib · for moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response | Not in a table | — | — | — | — | — |
| Jul 3, 2025 | EKTERLYsebetralstat · for acute attacks of hereditary angioedema | 110 | 60% | — | <1% | 6% | 9% |
| Jul 2, 2025 | LYNOZYFIClinvoseltamab-gcpt · for 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 | 80 | 36% | 36% | 14% | 3% | 13% |
| Jul 2, 2025 | ZEGFROVYsunvozertinib · 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 | 91 | 67% | 36% | 0% | 3% | 65% |
| Jun 17, 2025 | ANDEMBRYgaradacimab · To prevent attacks of hereditary angioedema | 39 | 62% | 0% | 0% | 3% | 10% |
| Jun 11, 2025 | IBTROZItaletrectinib · for locally advanced or metastatic ROS1-positive non-small cell lung cancer | 270 | 57% | 20% | <1% | <1% | 84% |
| Jun 9, 2025 | ENFLONSIAclesrovimab · for respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants | Not in a table | — | — | — | — | — |
| May 28, 2025 | TRYPTYRacoltremon · for the signs and symptoms of dry eye disease | 931 | 75% | 45% | 14% | 12% | 8% |
| May 14, 2025 | EMRELIStelisotuzumab vedotin-tllv · for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer | 168 | 30% | 50% | 2% | <1% | 33% |
| Apr 29, 2025 | IMAAVYnipocalimab-aahu · for generalized myasthenia gravis | 153 | 60% | 24% | 1% | 8% | 32% |
| Apr 28, 2025 | AVMAPKI FAKZYNJA CO-PACKavutometinib; defactinib · for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | 57 | 100% | 40% | 4% | 4% | 4% |
| Apr 23, 2025 | PENPULIMAB-KCQXpenpulimab-kcqx · for adult patients with metastatic or recurrent, locally advanced non-keratinizing nasopharyngeal cancer | Not in a table | — | — | — | — | — |
| Apr 2, 2025 | VANRAFIAatrasentan · To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Not in a table | — | — | — | — | — |
| Mar 28, 2025 | QFITLIAfitusiran · To prevent or reduce the frequency of bleeding episodes in hemophilia A or B | 120 | 0% | 1% | 1% | 4% | 62% |
| Mar 25, 2025 | BLUJEPAgepotidacin · For the treatment of female adult and pediatric patients 12 years of age and older | Not in a table | — | — | — | — | — |
| Feb 17, 2025 | ROMVIMZAvimseltinib · for symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity | 83 | 55% | 0% | 5% | 4% | 1% |
| Feb 11, 2025 | GOMEKLImirdametinib · For treatment in adults and children 2 years of age and older with neurofibromatosis type 1 (NF1) | 114 | 59% | 2% | 14% | 8% | 4% |
| Jan 30, 2025 | JOURNAVXsuzetrigine · For the treatment of moderate to severe acute pain in adults | 2,447 | 89% | 5% | 24% | 35% | 2% |
| Jan 21, 2025 | GRAFAPEXtreosulfan · For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients | 290 | 39% | 25% | — | — | — |
| Jan 17, 2025 | DATROWAYdatopotamab deruxtecan-dlnk · for unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease | 732 | 99% | 0% | 2% | 11% | 41% |
| Dec 20, 2024 | ALYFTREKvanzacaftor/tezacaftor/deutivacaftor · For the treatment of cystic fibrosis (CF) in patients 6 years of age and older | Not in a table | — | — | — | — | — |
| Dec 20, 2024 | ALHEMOconcizumab · For routine prophylaxis to prevent bleeding episodes in hemophilia A and B | Not in a table | — | — | — | — | — |
| Dec 19, 2024 | TRYNGOLZAolezarsen · for familial chylomicronemia syndrome | 23 | 52% | 13% | 0% | 13% | 0% |
| Dec 18, 2024 | ENSACOVEensartinib · for non-small cell lung cancer | 290 | 49% | 18% | 1% | 8% | 56% |
| Dec 13, 2024 | CRENESSITYcrinecerfont · for classic congenital adrenal hyperplasia | Not in a table | — | — | — | — | — |
| Dec 13, 2024 | UNLOXCYTcosibelimab-ipdl · for cutaneous squamous cell carcinoma | Not in a table | — | — | — | — | — |
| Dec 4, 2024 | BIZENGRIzenocutuzumab-zbco · for non-small cell lung cancer and pancreatic adenocarcinoma | 64 | 57% | 35% | 1% | 1% | 40% |
| Nov 27, 2024 | IOMERVUiomeprol · Is used during an arteriogram to visualize blood vessels in adult and pediatric patients | Not in a table | — | — | — | — | — |
| Nov 22, 2024 | RAPIBLYKlandiolol hydrochloride · For short-term reduction of ventricular rate in adults with supraventricular tachycardia. | Not in a table | — | — | — | — | — |
| Nov 22, 2024 | ATTRUBYacoramidis · for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis | Not in a table | — | — | — | — | — |
| Nov 20, 2024 | ZIIHERAzanidatamab-hrii · for unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer | 80 | 56% | 49% | 0% | 6% | 130% |
| Nov 15, 2024 | REVUFORJrevumenib · for relapsed or refractory acute leukemia | 104 | 64% | — | 8% | 22% | 10% |
| Oct 25, 2024 | ORLYNVAHsulopenem etzadroxil and probenecid · Treatment of uncomplicated urinary tract infections (uUTI) | Not in a table | — | — | — | — | — |
| Oct 18, 2024 | VYLOYzolbetuximab-clzb · for gastric or gastroesophageal junction adenocarcinoma | Not in a table | — | — | — | — | — |
| Oct 11, 2024 | HYMPAVZImarstacimab · To prevent or reduce bleeding episodes related to hemophilia A or B | 116 | 0% | <1% | <1% | 10% | 50% |
| Sep 27, 2024 | FLYRCADOflurpiridaz F 18 Injection · A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction | 1,333 | 32% | 46% | — | 9% | — |
| Sep 26, 2024 | COBENFYxanomeline tartrate and trospium chloride · for schizophrenia | 236 | 25% | <1% | 68% | 11% | <1% |
| Sep 24, 2024 | AQNEURSAlevacetylleucine · Treatment of Niemann-Pick disease type C | 60 | 45% | — | 0% | 0% | 3% |
| Sep 20, 2024 | MIPLYFFAarimoclomol · for Niemann-Pick disease type C | 39 | 56% | — | 0% | 5% | 5% |
| Sep 13, 2024 | EBGLYSSlebrikizumab-lbkz · An interleukin-13 antagonist indicated for the treatment of adult and pediatric patients 12 years of age and older | Not in a table | — | — | — | — | — |
| Aug 19, 2024 | LAZCLUZElazertinib · for non-small cell lung cancer | 429 | 64% | 45% | <1% | 13% | 58% |
| Aug 14, 2024 | NIKTIMVOaxatilimab-csfr · for chronic graft-versus-host disease (cGVHD) | 79 | 42% | 27% | 3% | 6% | 0% |
| Aug 14, 2024 | LIVDELZIseladelpar · for 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. | 193 | 95% | 21% | 2% | 29% | 6% |
| Aug 12, 2024 | NEMLUVIOnemolizumab-ilto · for prurigo nodularis | Not in a table | — | — | — | — | — |
| Aug 9, 2024 | YORVIPATHpalopegteriparatide · for hypoparathyroidism | 61 | 75% | 13% | 0% | 0% | 5% |
| Aug 6, 2024 | VORANIGOvorasidenib · Treatment of Grade 2 astrocytoma or oligodendroglioma | 168 | 40% | 0% | 1% | 5% | 3% |
| Jul 25, 2024 | LEQSELVIdeuruxolitinib · Indicated for the treatment of adults with severe alopecia areata (AA). | 1,209 | 64% | — | 9% | 8% | 6% |
| Jul 2, 2024 | KISUNLAdonanemab-azbt · for people with Alzheimer’s disease | 1,736 | 38% | 31% | 2% | 0% | 4% |
| Jun 26, 2024 | OHTUVAYREensifentrine · For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. | 978 | 47% | 55% | 4% | 4% | 1% |
| Jun 20, 2024 | PIASKYcrovalimab-akkz · Treatment of paroxysmal nocturnal hemoglobinuria | 204 | 45% | 11% | 2% | 12% | 67% |
| Jun 18, 2024 | SOFDRAsofpironium bromide · An anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. | Not in a table | — | — | — | — | — |
| Jun 10, 2024 | IQIRVOelafibranor · for 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 | 161 | 96% | 22% | 1% | — | 2% |
| Jun 6, 2024 | RYTELOimetelsta · to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemia | 178 | 38% | 80% | 2% | 6% | 6% |
| Apr 26, 2024 | XOLREMDImavorixafor · For the treatment of adults and adolescents over the age of 12 years with WHIM (Warts, Hypogammaglobulinemia, Infection, and Myelokathexis) syndrome | 17 | 53% | 12% | 0% | 0% | 6% |
| Apr 23, 2024 | OJEMDAtovorafenib · for certain types of brain tumors (cancers) called gliomas in patients 6 months and older | 76 | 47% | — | 3% | 4% | 7% |
| Apr 22, 2024 | ANKTIVAnogapendekin alfa inbakicept-pmnl · for a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS) | Not in a table | — | — | — | — | — |
| Apr 17, 2024 | LUMISIGHTpegulicianine · To use as an optical imaging agent for the detection of cancerous tissue | 406 | — | 48% | 6% | 3% | 5% |
| Apr 3, 2024 | ZEVTERAceftobiprole medocaril sodium for injection · Treatment of certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | 1,842 | 40% | 24% | 3% | 22% | 8% |
| Mar 29, 2024 | VOYDEYAdanicopan · for extravascular hemolysis with paroxysmal nocturnal hemoglobinuria | Not in a table | — | — | — | — | — |
| Mar 27, 2024 | VAFSEOvadadustat · for anemia due to chronic kidney disease | 3,923 | 44% | 34% | 24% | 38% | 5% |
| Mar 26, 2024 | WINREVAIRsotatercept-csrk · For the treatment of adults with pulmonary arterial hypertension | 323 | 78% | 3% | 3% | 18% | 2% |
| Mar 21, 2024 | DUVYZATgivinostat · Treatment of Duchenne muscular dystrophy in individuals aged 6 years and older | 81 | 0% | — | 0% | 7% | 4% |
| Mar 14, 2024 | REZDIFFRAresmetirom · for adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. | 888 | 56% | 26% | 2% | 21% | 3% |
| Mar 14, 2024 | TEVIMBRAtislelizumab-jsgr · for unresectable or metastatic esophageal squamous cell carcinoma | 512 | 16% | 38% | <1% | <1% | 80% |
| Feb 29, 2024 | LETYBOletibotulinumtoxinA · To temporarily improve the appearance of moderate-to-severe glabellar lines | 911 | 2% | <1% | 0% | <1% | 0% |
| Feb 22, 2024 | EXBLIFEPcefepime and enmetazobactam · For the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) | 678 | 60% | 0% | <1% | 8% | <1% |
| Jan 5, 2024 | ZELSUVMIberdazimer · Treatment of molluscum contagiosum | Not in a table | — | — | — | — | — |
| Dec 21, 2023 | WAINUAeplontersen · for polyneuropathy of hereditary transthyretin-mediated amyloidosis | 140 | 31% | 5% | 4% | 16% | 16% |
| Dec 18, 2023 | FILSUVEZbirch triterpenes · for wounds associated with dystrophic and junctional epidermolysis bullosa | 223 | 40% | — | 1% | 35% | 5% |
| Dec 8, 2023 | XENOVIEWxenon Xe 129 hyperpolarized · Evaluation of lung ventilation in adults and pediatric patients | 83 | 31% | — | 11% | 1% | 1% |
| Dec 7, 2023 | VTAMAtapinarof · Treatment of plaque psoriasis | Not in a table | — | — | — | — | — |
| Dec 5, 2023 | FABHLATAiptacopan · Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) | Not in a table | — | — | — | — | — |
| Nov 27, 2023 | OGSIVEOnirogacestat · for adults with progressing desmoid tumors who require systemic treatment | 72 | 65% | — | 7% | 13% | 4% |
| Nov 16, 2023 | TRUQAPcapivasertib · for breast cancer that meets certain disease criteria | Not in a table | — | — | — | — | — |
| Nov 15, 2023 | AUGTYROrepotrectinib · for ROS1-positive non-small cell lung cancer | 71 | 61% | — | 1% | 4% | 68% |
| Nov 15, 2023 | DEFENCATHtaurolidine, heparin · To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter. | 806 | 42% | 41% | 30% | 45% | 4% |
| Nov 11, 2023 | RYZNEUTAefbemalenograstim alfa-vuxw · for neutropenia | 280 | 70% | 9% | 0% | 70% | 0% |
| Nov 8, 2023 | FRUZAQLAfruquintinib · for refractory, metastatic colorectal cancer | 691 | 42% | 36% | 2% | 3% | 43% |
| Oct 26, 2023 | AGAMREEvamorolone · Treatment of Duchenne muscular dystrophy | 118 | 0% | — | 2% | 4% | 10% |
| Oct 17, 2023 | BIMZELXbimekizumab-bkzx · Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. | Not in a table | — | — | — | — | — |
| Oct 17, 2023 | ZILBRYSQzilucoplan · for generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | 174 | 57% | 28% | 7% | 7% | 12% |
| Oct 12, 2023 | VELSIPITYetrasimod · for moderately to severely active ulcerative colitis in adults | 408 | 45% | 7% | 2% | 5% | 0% |
| Sep 29, 2023 | RIVFLOZAnedosiran · To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | Not in a table | — | — | — | — | — |
| Sep 28, 2023 | POMBILITIcipaglucosidase alfa-atga · the treatment of adult patients with late-onset Pompe disease (LOPD) | 151 | 53% | 11% | <1% | — | 3% |
| Sep 22, 2023 | EXXUAgepirone · Treatment of major depressive disorder | 442 | 65% | <1% | 17% | 13% | 0% |
| Sep 15, 2023 | OJJAARAmomelotinib · to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemia | 195 | 37% | 79% | 2% | 6% | 9% |
| Sep 8, 2023 | APHEXDAmotixafortide · To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma | 80 | 31% | 46% | 10% | 11% | 3% |
| Aug 31, 2023 | XENPOZYMEolipudase alfa-rpcp · for Acid Sphingomyelinase Deficiency | 30 | 24% | 0% | 0% | 11% | 3% |
| Aug 18, 2023 | VEOPOZpozelimab-bbfg · for patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | 10 | 60% | — | 0% | — | 20% |
| Aug 16, 2023 | SOHONOSpalovarotene · 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 | 111 | 46% | — | 0% | — | 8% |
| Aug 14, 2023 | ELREXFIOelranatamab-bcmm · for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | 183 | 45% | 19% | 2% | 9% | 11% |
| Aug 10, 2023 | TALVEYtalquetamab-tgvs · for a form of blood cancer called multiple myeloma | Not in a table | — | — | — | — | — |
| Aug 4, 2023 | IZERVAYavacincaptad pegol intravitreal solution · for geographic atrophy secondary to age-related macular degeneration | 447 | 69% | 31% | <1% | 11% | <1% |
| Aug 4, 2023 | ZURZUVAEzuranolone · for postpartum depression | 196 | — | — | 31% | 31% | 1% |
| Jul 24, 2023 | XDEMVYlotilaner ophthalmic solution · for Demodex blepharitis, a type of eyelid infection. | Not in a table | — | — | — | — | — |
| Jul 20, 2023 | VANFLYTAquizartinib · To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria | 539 | 55% | 25% | 1% | 4% | 29% |
| Jul 17, 2023 | BEYFORTUSnirsevimab · Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease. | 614 | 48% | — | 10% | 16% | 6% |
| Jun 27, 2023 | NGENLAsomatrogon-ghla · Treatment of growth failure due to inadequate secretion of endogenous growth hormone | 224 | 28% | — | 0% | 11% | 20% |
| Jun 26, 2023 | RYSTIGGOrozanolixizumab-noli · for generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive | 200 | 61% | 25% | 3% | 7% | 11% |
| Jun 15, 2023 | COLUMVIglofitamab-gxbm · 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 | 145 | 34% | 54% | 1% | — | 5% |
| May 26, 2023 | INPEFAsotagliflozin · Treatment of heart failure | Not in a table | — | — | — | — | — |
| May 25, 2023 | PAXLOVIDnirmatrelvir, ritonavir · for mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 | Not in a table | — | — | — | — | — |
| May 25, 2023 | POSLUMAflotufolastat F 18 · To detect specific cancer lesions in males with prostate cancer | 747 | 0% | 62% | 12% | 5% | 2% |
| May 23, 2023 | XACDUROsulbactam for injection; durlobactam for injection · Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex | 128 | 26% | 22% | <1% | 14% | 45% |
| May 18, 2023 | MIEBOperfluorohexyloctane ophthalmic solution · Treatment for patients with the signs and symptoms of dry eye disease (DED) | 614 | 76% | 36% | 12% | 17% | 11% |
| May 12, 2023 | VEOZAHfezolinetant · for moderate to severe hot flashes caused by menopause | 2,852 | — | 0% | 17% | 21% | 1% |
| May 9, 2023 | ELFABRIOpegunigalsidase alfa-iwx · An enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients. | 93 | 40% | — | 6% | 5% | 0% |
| Apr 25, 2023 | QALSODYtofersen · Treatment of amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation | 72 | 40% | 13% | 1% | 6% | 7% |
| Mar 24, 2023 | JOENJAleniolisib · Treatment of activated phosphoinositide 3-kinase delta syndrome. | Not in a table | — | — | — | — | — |
| Mar 22, 2023 | ZAYOrezafungin for injection · for candidemia and invasive candidiasis | 166 | 44% | 41% | 5% | 7% | 20% |
| Mar 18, 2023 | ZTALMYganaxolone · for seizures in cyclin-dependent kinase-like 5 deficiency disorder | Not in a table | — | — | — | — | — |
| Mar 12, 2023 | DAYBUEtrofinetide · for Rett syndrome. | 187 | 100% | — | 1% | 9% | 3% |
| Mar 9, 2023 | ZAVZPRETzavegepant · for migraine | 1,056 | 85% | 4% | 14% | 21% | 3% |
| Feb 28, 2023 | SKYCLARYSomaveloxolone · for Friedrich’s ataxia | 103 | 47% | — | 0% | 5% | 0% |
| Feb 17, 2023 | FILSPARIsparsentan · To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | 281 | 31% | — | 1% | 7% | 35% |
| Feb 16, 2023 | LAMZEDEvelmanase alfa-tycv · for non-central nervous system manifestations of alpha-mannosidosis | 25 | 44% | — | 0% | — | 0% |
| Feb 1, 2023 | JESDUVROQdaprodustat · Treatment of anemia caused by chronic kidney disease for adults on dialysis for at least four months. | 2,964 | 43% | 11% | 16% | 25% | 12% |
| Jan 27, 2023 | JAYPIRCApirtobrutinib · for relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor | 128 | 20% | 43% | 2% | 2% | 14% |
| Jan 27, 2023 | ORSERDUelacestrant · for 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. | 237 | 97% | 43% | 2% | 8% | 7% |
| Jan 20, 2023 | BRENZAVVYbexagliflozin · To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise | 1,700 | 30% | 51% | 0% | 15% | 10% |
| Jan 6, 2023 | LEQEMBIlecanemab-irmb · Treatment of Alzheimer’s disease | 1,795 | 52% | 80% | 3% | 13% | 17% |
| Dec 28, 2022 | BRIUMVIublituximab-xiiy · for relapsing forms of multiple sclerosis | 1,093 | 64% | — | 2% | 2% | 0% |
| Dec 28, 2022 | NEXOBRIDanacaulase-bcdb · To remove charred tissue in adults with deep second degree and/or third degree burns from heat sources | 175 | 30% | 9% | 14% | 17% | 1% |
| Dec 22, 2022 | LUNSUMIOmosunetuzumab-axgb · for adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma | 90 | 39% | 33% | 4% | 8% | 9% |
| Dec 22, 2022 | SUNLENCAlenacapavir · for adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations | 72 | 25% | 8% | 38% | 21% | 21% |
| Dec 12, 2022 | KRAZATIadagrasib · Prescription medicine used to treat adult patients with non-small cell lung cancer | Not in a table | — | — | — | — | — |
| Dec 1, 2022 | REZLIDHIAolutasidenib · Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation | 153 | 48% | 44% | 3% | 0% | 3% |
| Nov 17, 2022 | TZIELDteplizumab-mzwv · Used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetes | 44 | 43% | — | 0% | 2% | 0% |
| Oct 25, 2022 | TECVAYLIteclistamab-cqyv · for relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy | Not in a table | — | — | — | — | — |
| Oct 21, 2022 | IMJUDOtremelimimab-actl · for unresectable hepatocellular carcinoma | 782 | 15% | 50% | 2% | 5% | 49% |
| Sep 30, 2022 | LYTGOBIfutibatinib · for intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements | 103 | 56% | 22% | 8% | 2% | 29% |
| Sep 29, 2022 | RELYVRIOsodium phenylbutyrate and taurursodiol · for amyotrophic lateral sclerosis (ALS) | 137 | 32% | 20% | 0% | 5% | 2% |
| Sep 22, 2022 | OMLONTIoomidenepag isopropyl · Reduces elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension | Not in a table | — | — | — | — | — |
| Sep 21, 2022 | ELUCIREMgadopiclenol · To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body | Not in a table | — | — | — | — | — |
| Sep 14, 2022 | TERLIVAZterlipressin · Treatment to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function | 199 | 40% | — | 6% | 16% | 3% |
| Sep 9, 2022 | ROLVEDONeflapegrastim · 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 | 643 | 100% | 30% | 12% | 17% | 8% |
| Sep 9, 2022 | SOTYKTUdeucravacitinib · for moderate-to-severe plaque psoriasis | Not in a table | — | — | — | — | — |
| Sep 7, 2022 | DAXXIFYdaxibotulinumtoxin A · for moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity. | 609 | 30% | — | 1% | 3% | 2% |
| Sep 1, 2022 | SPEVIGOspesolimab-sbzo · for generalized pustular psoriasis flares | Not in a table | — | — | — | — | — |
| May 13, 2022 | MOUNJAROtirzepatide · To improve blood sugar control in diabetes, in addition to diet and exercise | 7,769 | 43% | 32% | 4% | 43% | 14% |
| May 3, 2022 | VOQUEZNAvonoprazan fumarate, amoxicillin · Treatment of Helicobacter pylori infection | 349 | 60% | 19% | 6% | 27% | 1% |
| Apr 28, 2022 | CAMZYOSmavacamten · for certain classes of obstructive hypertrophic cardiomyopathy | 251 | 41% | 34% | 2% | 5% | 2% |
| Apr 26, 2022 | VIVJOAoteseconazole · To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential | Not in a table | — | — | — | — | — |
| Mar 23, 2022 | PLUVICTOlutetium Lu 177 vipivotide tetraxetan · for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies | 831 | 0% | 75% | 7% | 2% | 2% |
| Mar 18, 2022 | OPDUALAGnivolumab and relatlimab-rmbw · 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). | Not in a table | — | — | — | — | — |
| Feb 28, 2022 | VONJOpacritinib · for adult patients with a rare type of bone marrow disorder called myelofibrosis with platelet counts below 50,000/µL. | 32 | 50% | 78% | 0% | — | 0% |
| Feb 17, 2022 | PYRUKYNDmitapivat · Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency | 107 | 64% | 0% | 0% | 3% | 10% |
| Feb 4, 2022 | ENJAYMOsutimlimab-jome · To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease | 24 | 63% | 79% | 0% | 0% | 13% |
| Jan 28, 2022 | VABYSMOfaricimab-svoa · for neovascular (wet) aged-related macular degeneration and diabetic macular edema | Not in a table | — | — | — | — | — |
| Jan 25, 2022 | KIMMTRAKtebentafusp · for unresectable or metastatic uveal melanoma | Not in a table | — | — | — | — | — |
| Jan 14, 2022 | CIBINQOabrocitinib · Treatment of adults with refractory, moderate-to-severe atopic dermatitis | Not in a table | — | — | — | — | — |
| Jan 7, 2022 | QUVIVIQdaridorexant · Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. | 1,854 | 68% | 0% | 8% | 10% | 0% |
FDA posts a snapshot for each new molecular entity and some original biologics, with the demographics of the trials that supported approval. Shares are pooled across each snapshot's demographics tables, from the total column (or the column with the largest N). Participants is the largest single population FDA reports, since pooled tables can overlap. Some snapshots give demographics only as figures; they are listed without counts. Race and ethnicity are as participants reported them; a dash means the tables do not report it. FDA moved 2014 to 2022 snapshots to its web archive. Refreshed weekly. FDA, Drug Trials Snapshots