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Drug Trials Snapshots

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WHAT IS THE PURPOSE OF DRUG TRIALS SNAPSHOTS?

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

HOW TO USE SNAPSHOTS:

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

LIMITATIONS OF SNAPSHOTS:

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

GLOSSARY

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

Drug Active Ingredient Date of FDA Approval What is it Approved For Package Insert
ADDYI flibanserin August 18, 2015 Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Addyi
ADLYXIN lixisenatide July 27, 2016 Improvement of blood sugar control in adults with diabetes mellitus (DM) type 2 when used in addition to diet and exercise Adlyxin
AIMOVIG erenumab-aooe May 17, 2018 Preventive treatment of migraine in adults Aimovig
AJOVY fremanezumab-vfrm September 14, 2018 Preventive treatment of migraine in adults Ajovy
AKYNZEO fosnetupitant and palonosetron April 20, 2018 Prevention of the nausea and vomiting that happens right away or later in adults receiving certain anticancer medicines (chemotherapy) Akynzeo
ALECENSA alectinib December 11, 2015 Treatment of metastatic non-small cell lung cancer Alecensa
ALIQOPA copanlisib September 14, 2017 Treatment of  adults with follicular lymphoma whose disease has come back after at least two previous treatments. Aliqopa
ALUNBRIG brigatinib April 28, 2017 Treatment of a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). Alunbrig
ANNOVERA segesterone acetate and ethinyl estradiol vaginal system August 10, 2018 pregnancy prevention in women Annovera
ANTHIM obiltoxaximab March 18, 2016 Treatment of inhalational anthrax ANTHIM
ARISTADA aripiprazole laurixil October 5, 2015 Treatment of schizophrenia Aristada
AUSTEDO deutetrabenazine April 3, 2017 Treatment of chorea in patients with Huntington’s disease. Austedo
AVYCAZ ceftazidime-avibactam February 25, 2015 Treatment of complicated intra-abdominal infection (abbreviated as cIAI)  Avycaz
AVYCAZ ceftazidime-avibactam February 25, 2015 Treatment of complicated urinary tract infection (abbreviated as cUTI) Avycaz
AXUMIN fluciclovine F 18 May 27, 2016 Detection of prostate cancer recurrence Axumin
AZEDRA iobenguane I 131 July 30, 2018 Treatment of pheochromocytomas or paragangliomas Azedra
BAVENCIO avelumab March 23, 2017 Treatment of Merkel cell carcinoma Bavencio
BAXDELA delafloxacin June 19, 2017 Treatment of adult patients with bacterial skin infections. Baxdela
BENZNIDAZOLE Benznidazole August 29, 2017 Treatment of Chagas disease in children 2 to 12 years of age. Benznidazole
BESPONSA inotuzumab ozogamicin August 17, 2017 Treatment of  adults with B-cell acute lymphoblastic leukemia (ALL). Besponsa
BEVYXXA betrixaban June 23, 2017 Prevention of venous thromboembolism (VTE) Bevyxxa
BIKTARVY bictegravir/emtricitabine/tenofovir alafenamide February 7, 2018 Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. Biktarvy
BRAFTOVI encorafenib June 27, 2018 Treatment of  melanoma (a type of skin cancer)  when used with another drug binimetinib
 
Bractovi
BRIDION  sugammadex  December 15, 2015   Reversal of the effects of certain neuromuscular blocking agents  Bridion 
BRINEURA cerliponase alfa April 27, 2017 Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. Brineura
BRIVIACT  brivaracetam  February 18, 2016   Treatment of partial-onset seizures  Briviact 
CALQUENCE acalabrutinib October 31, 2017 Treatment of mantle cell lymphoma (MCL) Calquence 
CHOLBAM  cholic acid March 17, 2015 Treatment of bile acid synthesis disorders due to single enzyme defects  Cholbam 
CHOLBAM  cholic acid March 17, 2015 Treatment of peroxisomal disorders, including Zellweger spectrum disorders  Cholbam
CINQUAIR  reslizumab March 23, 2016 Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Cinquair
COPIKTRA duvelisib September 24, 2018 Treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL) Copiktra
CORLANOR  ivabradine April 15, 2015 Reduce hospitalization from worsening heart failure. Corlanor
COSENTYX secukinumab January 21, 2015 Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin Cosentyx
COTELLIC (cobimetinib) November 10, 2015 Part of combination treatment melanoma Cotellic
CRESEMBA isavuconazonium sulfate March 6, 2015 Treatment of invasive aspergillosis Cresemba
CRESEMBA isavuconazonium sulfate March 6, 2015 Treatment of invasive mucormycosis Cresemba
CRYSVITA burosamab-twza April 17, 2018 For the treatment of X-linked hypophosphatemia Crysvita
DAKLINZA daclatasvir July 24, 2015 Treatment of chronic Hepatitis C genotype 3 infection Daklinza
DALVANCE dalbavancin hydrochloride May 23, 2014 Treatment of serious bacterial skin infections Dalvance
DARZALEX daratumumab November 16, 2015 Treatment of multiple myeloma Darzalex
DEFITELIO defibrotide sodium March 30, 2016 Treatment of hepatic veno-occlusive disease (VOD) Defitelio
DIACOMIT stiripentol August 20, 2018 Treatment of seizures in patients with Dravet syndrome Diacomit
DOPTELET avatrombopag May 21, 2018 Treatment of adults with low platelet count Doptelet
DUPIXENT dupilumab March 28, 2017 Treatment of moderate to severe atopic dermatitis in adults Dupixent
EMFLAZA deflazacort February 9, 2017 Treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older Emflaza
EMPLICITI elotuzumab November 30, 2015 Treatment of multiple myeloma Empliciti
ENTRESTO sacubitril/valsartan July 7, 2015 Treatment of heart failure Entresto 
ENTYVIO vedolizumab May 20, 2014 Treatment of Crohn’s Disease Entyvio
ENTYVIO vedolizumab May 20, 2014 Treatment of Ulcerative Colitis Entyvio
EPCLUSA sofosbuvir and velpatasvir June 28, 2016 Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. Epclusa
EPIDIOLEX cannabidiol June 25, 2018 Treatment of seizures in two rare and severe forms of epilepsy. Epidiolex
ERLEADA apalutamide February 14, 2018 Treatment of prostate cancer that has not spread to other parts of the body (non-metastatic) Erleada
EUCRISA  crisaborole  December 14, 2016  Treatment of mild to moderate atopic dermatitis in patients 2 age years of age and older  Eucrisa 
EXONDYS 51 eteplirsen September 19, 2016  Treatment of particular type of Duchenne muscular dystrophy  Exondys 51
FARYDAK panobinostat February 23, 2015 Treatment of multiple myeloma Farydak
FASENRA benralizumab November 14, 2017 Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Fasenra
GALAFOLD migalastat hydrochloride August 10, 2018 Fabry disease in adults Galafold
GENVOYA elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide November 5, 2015 Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. Genvoya
GIAPREZA angiotensin II December 21, 2017 Used to increase dangerously low blood pressure in adults with certain types of shock. Giapreza
HEMLIBRA emicizumab November 16, 2017 Prevent ion or reduction of bleeding episodes in adults and children with hemophilia A. Hemlibra
IBRANCE palbociclib February 3, 2015 Treatment of a specific form of advanced breast cancer called ER-positive, HER2-negative (ER+/HER-) breast cancer in women who have gone through menopause (post-menopausal) Ibrance
IDHIFA enasidenib August 1, 2017 Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH2 and whose disease has come back or has not improved after previous treatment(s). IDHIFA
ILUMYA tildrakizumab-asmn March 20, 2018 For the treatment of moderate to severe plaque psoriasis Ilumya
IMFINZI durvalumab May 1, 2017 Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Imfinzi
INGREZZA valbenazine April 11, 2017 Treatment of tardive dyskinesia Ingrezza
JUBLIA efinaconazole June 6, 2014 Treatment of fungal infection of the toenails due to two common forms of fungi Jublia
KANUMA sebelipase alfa December 8, 2015 Treatment of Lysosomal Acid Lipase (LAL) deficiency Kanuma
KENGREAL cangrelor June 22, 2015 Prevention of coronary artery blood clot formation in patients undergoing PCI Kengreal
KEVZARA sarilumab May 22, 2017 Treatment  of adult patients with moderately to severely active rheumatoid arthritis (RA) Kevzara
KISQALI ribociclib March 13, 2017 Treatment of a specific form of advanced breast cancer Kisqali
KRINTAFEL tafenoquine July 20, 2018 Prevention of malaria relapse caused by the parasite, Plasmodium vivax Krintafel
KYBELLA deoxycholic acid April 29, 2015 Treatment for double chin Kybella
LARTRUVO olaratumab October 19, 2016 Treatment of soft tissue sarcoma Lartruvo
LENVIMA lenvatinib February 13, 2015 Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine  Lenvima
LIBTAYO cemiplimab-rwlc September 28, 2018 Treatment of  advanced skin cancer (squamous cell carcinoma) Libtayo
LOKELMA sodium zirconium cyclosilicate May 18, 2018 Treatment of hyperkalemia in adults Lokelma
LONSURF trifluridine and tipiracil September 22, 2015 Treatment of advanced colorectal cancer Lonsurf
LUCEMYRA lofexidine hydrochloride May 16, 2018 For the treatment of symptoms associated with opioid withdrawal during abrupt opioid discontinuation. Lucemyra
LUMOXITI moxetumomab pasudotox-tdfk September 13, 2018 Treatment of hairy cell leukemia in adults Lumoxiti
LUTATHERA lutetium 177 dotate January 26, 2018 For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) Lutathera
MACRILEN macimorelin acetate  December 20, 2017  Diagnosis of growth hormone deficiency in adults  Macrilen
MAVYRET glecaprevir and pibrentasvir August 3, 2017 Treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection Mavyret
MEKTOVI binimetinib June 27, 2018 Treatment of  melanoma (a type of skin cancer)  when used with another drug encorafenib. Mektovi
MEPSEVII vestronidase alfa-vjbk November 15, 2017 Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome) Mepsevii
MOXIDECTIN moxidectin June 13, 2018 Treatment of onchocerciasis in patients 12 years of age and older Moxidectin
MULPLETA lusutrombopag July 31,, 2018 Treatment of adults with low platelet count Mulpleta
NATPARA parathyroid hormone January 25, 2015 Control of hypocalcemia along with calcium and vitamin D in adults with hypoparathyroidism Natpara
NERLYNX neratinib July 17, 2017 Treatment of an early stage HER2 -positive breast cancer. Nerlynx
NETSPOT kit for the preparation of gallium Ga 68 dotatate injection June 1, 2016 Detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) Netspot
NINLARO ixazomib  November 20, 2015  Treatment of multiple myeloma  Ninlaro 
NUCALA mepolizumab November 4, 2015 Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Nucala
NUPLAZID pimavanserin April 29, 2016 Treatment of hallucinations and delusions in patients with Parkinson’s disease Nuplazid
OCALIVA obeticholic acid May 27, 2016 Treatment of primary biliary cholangitis in adults Ocaliva
ODOMZO  sonidegib July 24, 2015 Treatment of locally advanced basal cell carcinoma  Odomzo
OCREVUS ocrelizumab March 28, 2017 Treatment of patients with two types of multiple sclerosis Ocrevus
OLUMIANT baricitinib May 31, 2018 Treatment of adult patients with rheumatoid arthritis (RA) whose disease was not well controlled using RA medications called Tumor Necrosis Factor (TNF) antagonists Olumiant
OMEGAVEN fish oil triglycerides July 27, 2018 Parenteral nutrition-associated cholestasis (PNAC) Omegaven
ONPATTRO patisiran August 10, 2018 Nerve dmage in adult patients with hereditary tranthyretin-mediated amyloidosis Onpattro
ORILISSA elagolix July 23, 2018 Treatment of moderate to severe pain associated with endometriosis Orilissa
ORKAMBI lumacaftor/ivacaftor July 2, 2015 Treatment of cystic fibrosis Orkambi
OXERVATE cenegermin-bkbj August 22, 2018 Treatment of neurotrophic keratitis  Oxervate
OZEMPIC  semaglutide  December 5, 2017  Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise.  Ozempic 
PALYNZIQ pegvaliase-pqpz May 24, 2018 Lowering the blood levels of phenylalanine in adults with phenylketonuria (PKU) Palynziq
PARSABIV etelcalcetide February 7, 2017 Treat high levels of parathyroid hormone (PTH) Parsabiv
PIFELTRO doravirine August 30, 2018 Treatment of HIV-1 infection in adults Pifeltro
PORTRAZZA necitumumab November 24, 2015 Treatment of metastatic squamous non-small cell lung cancer Portrazza
POTELIGEO mogamulizumab-kpkc August 8, 2018 Treatment of  adults with mycosis fungoides or Sézary syndrome Poteligeo
PRALUENT  alirocumab July 24, 2015 Treatment of certain patients with high cholesterol  Praluent 
PRAXBIND idarucizumab October 16, 2015 Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects. Praxbind
PREVYMIS letermovir November 8, 2017 Prevention of cytomegalovirus (CMV) infection and disease in adults. Prevymis
RADICAVA edaravone May 5, 2017 Treatment of Amyotrophic Lateral Sclerosis (ALS) Radicava
REPATHA evolocumab August 27, 2015 Treatment of certain patients with high cholesterol Repatha
REXULTI brexpiprazole July 10, 2015 Treatment of major depressive disorder Rexulti 
REXULTI brexpiprazole July 10, 2015 Treatment of schizophrenia Rexulti
RHOPRESSA netarsudil December 18, 2017 Reducing elevated intraocular pressure, when the pressure inside the eye is too high. Rhopressa
RUBRACA rucaparib December 19, 2016 Treatment of women with certain type of advanced ovarian cancer Rubraca
RYDAPT midostaurin April 28, 2017 Treatment of adults with acute myeloid leukemia (AML) that has a mutation in a gene called FLT3, in combination with chemotherapy. Rydapt 
RYDAPT midostaurin April 28, 2017 Treatment of adults with advanced systemic mastocytosis (SM). Rydapt 
RYZODEG insulin degludec and insulin aspart injection September 26, 2015 Improves blood sugar control in adults with diabetes mellitus (DM) Ryzodeg
SAVAYSA edoxaban January 8, 2015  Prevention of stroke in patients with atrial fibrillation Savaysa  
SILIQ brodalumab February 15, 2017 SILIQ is used for treatment of moderate to severe plaque psoriasis in adults Siliq
SAVAYSA edoxaban January 8, 2015 Reduction of risk of venous thromboembolism (VTE) in patients with previous VTE Savaysa
SEYSARA sarecycline October 1, 2018 For the treatment of certain types of acne vulgaris in patients 9 years and older Seysara
SIVEXTRO tedizolid June 20, 2014 Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infections Sivextro
SOLOSEC secnidazole September 15, 2017 Used to treat adult women with vaginal infections caused by bacteria known as bacterial vaginosis Solosec
SPINRAZA nusinersen December 23, 2016 Treatment of spinal muscular atrophy SPINRAZA
STEGLATRO ertugliflozin December 19, 2017 Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. Steglatro
STIOLTO RESPIMAT tiotropium bromide and olodaterol May 21, 2015 Long-term treatment of COPD Stiolto Respimat
STRENSIQ asfotase alfa  October 23, 2015  Treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP)  Strensiq 
SYMDEKO tezacaftor/ivacaftor February 12, 2018 For the treatment of cystic fibrosis Symdeko
SYMPROIC naldemedine March 23, 2017 Treatment for adults with constipation caused by prescription pain drugs called opioids. Symproic
TAGRISSO osimertinib  December 3, 2015 Treatment of patients with advanced non-small cell lung cancer (NSCLC)   Tagrisso 
TAKHZYRO lanadelumab-flyo August 23, 2018 Prevent attacks of hereditary angioedema in people 12 years and older Takhzyro
TALTZ ixekizumab March 22, 2016 Treatment of moderate to severe plaque psoriasis in adults Taltz
TAVALISSE fostamatinib disodium hexahydrate April 17, 2018 Treatment of  adults with low platelet count due to chronic immune thrombocytopenia (ITP) Tavalisse
TECENTRIQ atezolizumab May 18, 2016 Treatment of a type of bladder cancer called urothelial carcinoma Tecentriq
TIBSOVO ivosidenib July 20, 2018 Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH1 and whose disease has come back or has not improved after previous treatment(s) Tibsovo
TPOXX tecovirimat July 13, 2018 Treatment of smallpox disease Tpoxx
TREMFYA guselkumab July 13, 2017  treatment of moderate to severe plaque psoriasis in adults Tremfya
TRESIBA insulin degludec injection  September 26, 2015  Improve glucose control in adults with diabetes mellitus  Tresiba 
TROGARZO ibalizumab-uiyk March 6, 2018 Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. Trogarzo
TRULANCE plecanatide January 19, 2017 Treatment of chronic idiopathic constipation in adults Trulance
TYMLOS abaloparatide April 28, 2017 Treatment of postmenopausal women with osteoporosis who are at high risk for bone fracture Tymlos
UNITUXIN  dinutuximab March 10, 2015 Treatment of children with high-risk neuroblastoma Unituxin
UPTRAVI selexipag December 21, 2015 Treatment of adults with pulmonary artery hypertension Uptravi
VABOMERE meropenem and vaborbactam August 29, 2017 Treatment of adults who have a complicated urinary tract infection (abbreviated as cUTI) Vabomere
VARUBI rolapitant September 1, 2015 Prevent delayed phase chemotherapy-induced nausea and vomiting Varubi
VELTASSA patiromer October 21, 2015 Treatment of hyperkalemia Veltassa
VENCLEXTA venetoclax April 11, 2016 Treatment of chronic lymphocytic leukemia (CLL) Venclexta
VERZENIO abemaciclib September 28, 2017 Treatment of specific forms of breast cancer Verzenio
VIBERZI eluxadoline May 27, 2015 Treatment of irritable bowel syndrome with diarrhea Viberzi
VISTOGARD uridine triacetate December 11, 2015 Emergency treatment of an overdose with fluorouracil or capecitabine Vistogard
VIZIMPRO dacomitinib September 27, 2018 Treatment of advanced non-small cell lung cancer Vizimpro
VOSEVI sofosbuvir,velpatasvir and voxilaprevir July 18, 2017 Treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection  Vosevi
VRAYLAR cariprazine September 17, 2015 Treatment of bipolar disorder Vraylar
VRAYLAR cariprazine September 17, 2015 Treatment of schizophrenia Vraylar
VYZULTA latanoprostene bunod November 2, 2017  Reducing elevated intraocular pressure (IOP) Vyzulta
XADAGO safinamide March 21, 2017 Treatment of “off episodes” in patients with Parkinson’s disease. Xadago
XEPI ozenoxacin December 11,2017 treatment of impetigo due to certain bacteria Xepi
XERAVA eravacycline August 27, 2018 complicated intra-abdominal infections caused by bacteria in patients 18 years and older Xerava
XERMELO telotristat ethyl February 28, 2017 Treatment of diarrhea in adult patients with carcinoid syndrome Xermelo
XIIDRA lifitegrast July 11, 2016 Treatment of the signs and symptoms of dry eye disease. Xiidra
XURIDEN uridine triacetate September 4, 2015 Treatment of patients with hereditary orotic aciduria Xuriden
YONDELIS  trabectedin  October 23, 2015  Treatment of certain types of advances tissue sarcoma   Yondelis 
ZEJULA niraparib March 27, 2017 Treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer Zejula 
ZEMDRI plazomicin June 25, 2018 Treatment of adults who have a complicated urinary tract infection Zemdri
ZEPATIER elbasvir and grazoprevir January 28, 2016 Treatment of chronic Hepatis C genotypes 1 or 4 infection Zepatier
ZINBRYTA daclizumab May 27, 2016 Treatment of relapsing forms of multiple sclerosis (MS) Zinbryta
ZINPLAVA bezlotoxumab October 21, 2016 Decreasing the risk of Clostridium difficile infection recurrence Zinplava
ZONTIVITY vorapaxar May 8, 2014 Reduction of heart attacks and stroke in high-risk patients Zontivity
ZURAMPIC lesinurad December 22, 2015 Lowering uric acid levels in the blood of adult patients with gout Zurampic 

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Page Last Updated: 10/16/2018
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