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FDA New Molecular Entities [2011-November 2024] 第3頁
| Drug Name | Active Ingredient | Combo/single | ATC Index | AHFS Class | Date of Approval | Mechanism | Treatment | TFDA approval | |
| 352 | Natpara | parathyroid hormone | Single | H05AA03 | 68:24 | 2015/2/13 | raises serum Ca by increasing intestinal Ca absorption | To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism | |
| 353 | Tymlos | abaloparatide | Single | H05AA04 | 68:24 | 2017/5/5 | PTH1 receptor agonist | To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies | |
| 354 | Yorvipath | palopegteriparatide | Single | H05AA05 | 68:24 | 2024/8/9 | PTH | To treat hypoparathyroidism | |
| 355 | Sogroya | somapacitan-beco | Single | H01AC07 | 68:28 | 2020/9/4 | binds to GH receptor in targeted cells, producing a signal | Growth hormone | |
| 356 | Ngenla | somatrogon-ghla | Single | H01AC08 | 68:28 | 2023/6/27 | growth hormone receptor agonist | To treat growth failure due to inadequate secretion of endogenous growth hormone | |
| 357 | Skytrofa | lonapegsomatropin-tcgd | Single | H01AC09 | 68:28 | 2021/8/25 | releases somatropin, which binds to growth hormone receptor | To treat short stature due to inadequate secretion of endogenous growth hormone | |
| 358 | Terlivaz | terlipressin | Single | H01BA04 | 68:28 | 2022/9/14 | vasopressin receptor agonist | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | |
| 359 | Signifor | pasereotide | Single | H01CB05 | 68:29 | 2012/12/21 | To treat Cushing’s disease patients who cannot be helped through surgery | ||
| 360 | Myalept | metreleptin for injection | Single | A16AA07 | 68:40 | 2014/3/19 | binds and activates leptin receptor | To treat the complications of leptin deficiency | |
| 361 | Giapreza | angiotensin II | Single | C01CX09 | 68:44 | 2018/2/7 | binds AT-1 receptors and causes vasoconstriction | To increase blood pressure in adults with septic or other distributive shock | |
| 362 | Pylarify | piflufolastat F 18 | Single | V09IX16 | 78:00 | 2021/5/27 | attachment to PSMA | To identify prostate-specific membrane antigen-positive lesions in prostate cancer | |
| 363 | Xofigo | radium Ra 223 dichloride | Single | V10XX03 | 78:00 | 2013/5/29 | To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. | ||
| 364 | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | Single | V10XX05 | 78:00 | 2022/3/23 | PSMA radioligand | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies | |
| 365 | Egaten | triclabendazole | Single | P02BX04 | 8:08 | 2019/3/20 | reduces resting membrane potential and inhibits tubulin function in worms | To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” | |
| 366 | Moxidectin | moxidectin | Single | P02CX03 | 8:08 | 2018/6/25 | binds GluCl, GABA receptors, and ABC transporters, leading to muscle paralysis in nematodes | To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older | |
| 367 | Aemcolo | rifamycin | Single | A07AA13 D06AX15 J04AB03 S01AA16 S02AA12 |
8:12 | 2018/11/21 | inhibits beta subunit of bacterial DNA-dependent RNA polymerase | To treat travelers’ diarrhea | |
| 368 | Xerava | eravacycline | Single | J01AA13 | 8:12 | 2018/9/13 | binds 30S ribosomal subunit to disrupt bacterial protein synthesis | To treat complicated intra-abdominal infections in patients 18 years of age and older | |
| 369 | Seysara | sarecycline | Single | J01AA14 | 8:12 | 2018/10/5 | binds bacterial 70S ribosomal subunit to block protein synthesis | To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older | |
| 370 | Nuzyra | omadacycline | Single | J01AA15 | 8:12 | 2018/10/5 | overcome tetracycline resistance via efflux and ribosomal protection | To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections | |
| 371 | Avycaz | ceftazidime-avibactam | Single | J01DD02 | 8:12 | 2015/3/10 | non–beta-lactam beta-lactamase inhibitor | To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. | |
| 372 | Exblifep | cefepime, enmetazobactam | Combo | J01DE51 | 8:12 | 2024/2/22 | cephalosporin and beta-lactamase inhibitor | To treat complicated urinary tract infections | |
| 373 | Vabomere | meropenem, vaborbactam | Combo | J01DH52 | 8:12 | 2017/9/14 | PBP inhibitor | To treat adults with complicated urinary tract infections | |
| 374 | Recarbrio | imipenem, cilastatin, relebactam | Combo | J01DH56 | 8:12 | 2019/7/30 | PBP inhibitor | To treat complicated urinary tract and complicated intra-abdominal infections | |
| 375 | Zevtera | ceftobiprole medocaril sodium | Single | J01DI01 | 8:12 | 2024/4/3 | cephalosporin | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | |
| 376 | Fetroja | cefiderocol | Single | J01DI04 | 8:12 | 2019/11/20 | PBP inhibitor | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options | |
| 377 | Zerbaxa | ceftolozane, tazobactam | Combo | J01DI54 | 8:12 | 2014/12/22 | PBP inhibitor | To treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) | |
| 378 | Zemdri | plazomicin | Single | J01GB14 | 8:12 | 2018/6/27 | binds bacterial 30S ribosomal subunit to inhibit protein synthesis | To treat adults with complicated urinary tract infections | |
| 379 | Baxdela | delafloxacin | Single | J01MA23 | 8:12 | 2017/7/13 | topoisomerase IV and DNA gyrase inhibitor | To treat patients with acute bacterial skin infections | |
| 380 | Dalvance | dalbavancin | Single | J01XA04 | 8:12 | 2014/6/20 | binds D-alanyl-D- alanine terminus to inhibit bacterial cell wall biosythesis | To treat adults with skin infections | |
| 381 | Orbactiv | oritavancin | Single | J01XA05 | 8:12 | 2014/8/15 | transglycosylation inhibitor | To treat adults with skin infections | |
| 382 | Sivextro (tablet) Sivextro (injection) |
tedizolid phosphate | Single | J01XX11 | 8:12 | 2014/7/7 | binds 50S of bacterial ribosome to inhibit protein synthesis | To treat adults with skin infections | |
| 383 | Xenleta | lefamulin | Single | J01XX12 | 8:12 | 2019/8/27 | inhibits bacterial protein synthesis by binding to PTC of 50S ribosome | To treat adults with community-acquired bacterial pneumonia | |
| 384 | Xacduro | sulbactam, durlobactam | Combo | 8:12 | 2023/5/23 | beta-lactamase inhibitor combination | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex | ||
| 385 | Vivjoa | oteseconazole | Single | J02AC06 | 8:14 | 2022/4/26 | azole antifungal | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential | |
| 386 | Brexafemme | ibrexafungerp | Single | J02AX07 | 8:14 | 2021/6/1 | glucan synthase inhibitor | To treat vulvovaginal candidiasis | |
| 387 | Rezzayo | rezafungin | Single | J02AX08 | 8:14 | 2023/3/22 | echinocandin antifungal | To treat candidemia and invasive candidiasis | |
| 388 | Cresemba | isavuconazonium sulfate | Single | 8:14 | 2015/3/17 | ergosterol synthesis inhibitor | To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections | ||
| 389 | drug name N/A | pretomanid | Single | J04AK08 | 8:16 | 2019/8/15 | inhibits mycolic acid biosynthesis blocks cell wall of mycobacterium | For treatment-resistant forms of tuberculosis that affects the lungs | |
| 390 | Veklury | remdesivir | Single | J05AB16 | 8:18 | 2020/11/23 | SARS-CoV-2 RNA polymerase inhibitor | To treat COVID-19 | |
| 391 | Paxlovid | nirmatrelvir, ritonavir | Combo | J05AE30 | 8:18 | 2023/5/25 | SARS-CoV-2 protease inhibitor | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 | |
| 392 | Pifeltro | doravirine | Single | J05AG06 | 8:18 | 2018/9/14 | HIV-1 RT inhibitor | To treat HIV-1 infection in adult patients | |
| 393 | Rapivab | peramivir | Single | J05AH03 | 8:18 | 2015/1/8 | neuraminidase inhibitor | To treat influenza infection in adults | |
| 394 | Tivicay | dolutegravir | Single | J05AJ03 | 8:18 | 2013/10/3 | To treat HIV-1 infection. | ||
| 395 | Cabenuva | cabotegravir, rilpivirine | Combo | J05AJ04 | 8:18 | 2021/2/3 | retroviral DNA integration inhibitor | To treat HIV | |
| 396 | Olysio | simeprevir | Single | J05AP05 | 8:18 | 2013/12/18 | HCV NS3/4A protease inhibitor | To treat chronic hepatitis C virus infection. | |
| 397 | Daklinza | daclatasvir | Single | J05AP07 | 8:18 | 2015/8/27 | viral RNA replication inhibitor | To treat chronic hepatitis C virus (HCV) genotype 3 infections | |
| 398 | Sovaldi | sofosbuvir | Single | J05AP08 | 8:18 | 2014/1/8 | HCV NS5B polymerase analog inhibitor | To treat chronic hepatitis C virus (HCV) infection. | |
| 399 | Harvoni | ledipasvir, sofosbuvir | Combo | J05AP51 | 8:18 | 2014/10/10 | To treat chronic hepatitis C virus (HCV) genotype 1 infection | ||
| 400 | Viekira Pak | ombitasvir, paritaprevir, ritonavir tablets with dasabuvir tablets | Combo | J05AP52 | 8:18 | 2014/12/19 | HIV protease inhibitor (ritonavir), NS4A inhibitor (ombitasvir), DNA replicase inhibitor (dasabuvir), NS3/4A inhibitor (paritaprevir) | To treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis | |
| 401 | Zepatier | elbasvir, grazoprevir | Combo | J05AP54 | 8:18 | 2016/3/18 | NS3/4A protease inhibitor combined with NS5A replication complex inhibitor | To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. | |
| 402 | Epclusa | sofosbuvir, velpatasvir | Combo | J05AP55 | 8:18 | 2016/7/27 | HCV NS5B RNA polymerase inhibitor | To treat all six major forms of hepatitis C virus | |
| 403 | Vosevi | sofosbuvir, velpatasvir, voxilaprevir | Combo | J05AP56 | 8:18 | 2017/8/3 | HCV NS5B RNA polymerase inhibitor | To treat adults with chronic hepatitis C virus | |
| 404 | Mavyret | glecaprevir, pibrentasvir | Combo | J05AP57 | 8:18 | 2017/8/29 | NS3/4A protease inhibitor | To treat adults with chronic hepatitis C virus | |
| 405 | Genvoya | elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide | Combo | J05AR18 | 8:18 | 2015/11/13 | four-drug combination of an HIV-1 INSTI, CYP3A inhibitor, TAF, and HIV-1 NRTI. | For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older | |
| 406 | Biktarvy | bictegravir, embitcitabine, tenofovir alafenamide | Combo | J05AR20 | 8:18 | 2018/2/14 | HIV-1 integrase inhibitor | To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen | |
| 407 | Livtencity | maribavir | Single | J05AX10 | 8:18 | 2021/11/23 | CMV pUL97 viral protein kinase inhibitor | To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV | |
| 408 | Prevymis | letermovir | Single | J05AX18 | 8:18 | 2017/11/15 | CMV DNA terminase complex inhibitor | To prevent infection after bone marrow transplant | |
| 409 | Trogarzo | ibalizumab-uiyk | Single | J05AX23 | 8:18 | 2018/4/17 | HIV-1 viral entry inhibitor | To treat HIV patients who have limited treatment options | |
| 410 | TPOXX | tecovirimat | Single | J05AX24 | 8:18 | 2018/7/20 | orthopoxvirus VP37 protein inhibitor | To treat smallpox | |
| 411 | Xofluza | baloxavir marboxil | Single | J05AX25 | 8:18 | 2018/11/9 | inhibits endonuclease activity of PA protein in influenza virus | To treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. | |
| 412 | Rukobia | fostemsavir | Single | J05AX29 | 8:18 | 2020/7/24 | binds gp120 protein on HIV-1 to prevent it from attaching to host cell | To treat HIV | |
| 413 | Sunlenca | lenacapavir | Single | J05AX31 | 8:18 | 2022/12/22 | HIV-1 capsid inhibitor | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations | |
| 414 | Ebanga | ansuvimab-zykl | Single | J06BD04 | 8:18 | 2021/1/19 | binds glycan cap and inner chalice of EBOV GP1 subunit to block viral cell entry | To treat ebola | |
| 415 | Beyfortus | nirsevimab-alip | Single | J06BD08 | 8:18 | 2023/7/17 | RSV F protein-directed fusion inhibitor | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease | |
| 416 | Edurant | rilpivirine | Single | 8:18 | 2011/5/20 | reverse transcriptase inhibitor against HIV-1 | For the treatment of HIV-1 infection in adults who have never taken HIV therapy. | ||
| 417 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | Combo | 8:18 | 2020/11/20 | three antibodies neutralize viral particles and recruit immune effectors | To treat ebola virus | ||
| 418 | Solosec | secnidazole | Single | P01AB07 | 8:30 | 2017/10/31 | an inactive prodrug that gets reduced by bacterial enzymes into radical anions | To treat bacterial vaginosis | |
| 419 | Krintafel | tafenoquine | Single | P01BA07 | 8:30 | 2018/7/27 | produces hydrogen peroxide and hydroxyl radicals to kill parasite | For the radical cure (prevention of relapse) of Plasmodium vivax malaria | |
| 420 | Artesunate | artesunate | Single | P01BE03 | 8:30 | 2020/6/11 | heme polymerization inhibitor | To treat severe malaria | |
| 421 | benznidazole | benznidazole | Single | P01CA02 | 8:30 | 2017/9/15 | inhibits DNA, RNA and protein synthesis in T. cruzi parasite | To treat children ages 2 to 12 years old with Chagas disease | |
| 422 | Fexinidazole | fexinidazole | Single | P01CA03 | 8:30 | 2021/7/16 | activated by bacterial-like nitroreductases encoded by trypanosomes, forming reactive intermediates that damage DNA and proteins | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | |
| 423 | Lampit | nifurtimox | Single | P01CC01 | 8:30 | 2020/8/7 | forms nitro-anion radical metabolite that causes DNA breakdown | To treat Chagas disease in certain pediatric patients younger than age 18 | |
| 424 | Impavido | miltefosine | Single | P01CX04 | 8:30 | 2014/4/15 | interacts with membrane lipids and causes apoptosis in leishmania parasites | To treat a tropical disease called leishmaniasis | |
| 425 | Orlynvah | sulopenem etzadroxil, probenecid | Combo | 8:36 | 2024/10/25 | penem antibacterial drug, renal tubular inhibitor | To treat uncomplicated urinary tract infections (uUTI) | ||
| 426 | Zinplava | bezlotoxumab | Single | J06BC03 | 80:04 | 2016/12/19 | binds C. difficile toxin B to neutralize its toxic effects on mammalian cells | To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older | |
| 427 | Anthim | obiltoxaximab | Single | J06BC04 | 80:04 | 2016/3/23 | binds free PA to prevent anthrax toxins from entering cells | To treat inhalational anthrax in combination with appropriate antibacterial drugs. | |
| 428 | Luzu | luliconozole | Single | D01AC18 | 84:04 | 2013/12/6 | lanosterol demethylase inhibitor | For the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. | |
| 429 | Jublia | efinaconazole | Single | D01AC19 | 84:04 | 2014/7/3 | fungal lanosterol 14α-demethylase inhibitor | Treat mild to moderate onychomycosis (fungal infection) | |
| 430 | Kerydin | tavaborole | Single | D01AE24 | 84:04 | 2014/7/31 | tRNA synthetase inhibitor | For the topical treatment of onychomycosis of the toenails | |
| 431 | Xepi | ozenoxacin | Single | D06AX14 | 84:04 | 2017/12/19 | DNA gyrase A and topoisomerase IV inhibitor | To treat impetigo | |
| 432 | Xeglyze | abametapir | Single | P03AX07 | 84:04 | 2020/8/5 | metalloproteinase inhibitor | To treat head lice | |
| 433 | Zelsuvmi | berdazimer | Single | 84:04 | 2024/1/5 | nitric oxide releasing agent | To treat molluscum contagiosum | ||
| 434 | Vtama | tapinarof | Single | D05AX07 | 84:06 | 2022/5/23 | AhR agonist | To treat plaque psoriasis | |
| 435 | Eucrisa | crisaborole | Single | D11AH06 | 84:06 | 2016/12/23 | PDE4 inhibitor | To treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older | |
| 436 | Ebglyss | lebrikizumab-lbkz | Single | D11AH10 | 84:06 | 2024/9/13 | mab, IL-13 | To treat moderate-to-severe atopic dermatitis | |
| 437 | Nemluvio | nemolizumab-ilto | Single | D11AH12 | 84:06 | 2024/8/12 | mab, IL-31 | To treat prurigo nodularis | |
| 438 | Leqselvi | deuruxolitinib | Single | 84:06 | 2024/7/25 | JAK inhibitor | To treat severe alopecia areata | ||
| 439 | Sofdra | sofpironium | Single | 84:12 | 2024/6/18 | acetylcholine antagonist | To treat primary axillary hyperhidrosis | ||
| 440 | Scenesse | afamelanotide | Single | D02BB02 | 84:92 | 2019/10/11 | MC1-R agonist | To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria | |
| 441 | Klisyri | tirbanibulin | Single | D06BX03 | 84:92 | 2020/12/18 | inhibitor of tubulin polymerization and Src kinase signaling | To treat actinic Keratosis of the face or scalp | |
| 442 | Aklief | trifarotene | Single | D10AD06 | 84:92 | 2019/10/8 | RAR agonist | For the topical treatment of acne vulgaris in patients 9 years of age and older | |
| 443 | Winlevi | clascoterone | Single | D10AX06 | 84:92 | 2020/9/3 | androgen receptor inhibitor | To treat acne | |
| 444 | Dupixent | dupilumab | Single | D11AH05 | 84:92 | 2017/4/3 | IL-4 and IL-13 signaling inhibitor | To treat adults with moderate-to-severe eczema (atopic dermatitis) | |
| 445 | Adbry | tralokinumab-ldrm | Single | D11AH07 | 84:92 | 2021/12/27 | IL-13 inhibitor | To treat moderate-to-severe atopic dermatitis | |
| 446 | Cibinqo | abrocitinib | Single | D11AH08 | 84:92 | 2022/1/14 | JAK inhibitor | To treat refractory, moderate-to-severe atopic dermatitis | |
| 447 | Cosentyx | secukinumab | Single | L04AC10 | 84:92 | 2015/2/3 | IL-17A inhibitor | To treat adults with moderate-to-severe plaque psoriasis |
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| 448 | Siliq | brodalumab | Single | L04AC12 | 84:92 | 2017/3/13 | IL-17RA inhibitor | To treat adults with moderate-to-severe plaque psoriasis | |
| 449 | Taltz | ixekizumab | Single | L04AC13 | 84:92 | 2016/3/30 | IL-17A inhibitor | To treat adults with combined with moderate-to-severe plaque psoriasis. | |
| 450 | Tremfya | guselkumab | Single | L04AC16 | 84:92 | 2017/7/18 | IL-23 inhibitor | For the treatment of adult patients with moderate-to-severe plaque psoriasis | |
| 451 | Ilumya | tildrakizumab | Single | L04AC17 | 84:92 | 2018/4/17 | IL-23 inhibitor | To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy | |
| 452 | Skyrizi | risankizumab-rzaa | Single | L04AC18 | 84:92 | 2019/5/24 | IL-23 inhibitor | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | |
| 453 | Bimzelx | bimekizumab | Single | L04AC21 | 84:92 | 2023/10/17 | IL-17 antagonist | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | |
| 454 | Spevigo | spesolimab-sbzo | Single | L04AC22 | 84:92 | 2022/9/1 | IL-36 antagonist | To treat generalized pustular psoriasis flares | |
| 455 | Sotyktu | deucravacitinib | Single | L04AF07 | 84:92 | 2022/9/9 | TYK2 inhibitor | To treat moderate-to-severe plaque psoriasis | |
| 456 | Litfulo | ritlecitinib | Single | L04AF08 | 84:92 | 2023/6/23 | JAK3 TKI | To treat severely patchy hair loss | |
| 457 | Korsuva | difelikefalin | Single | V03AX04 | 84:92 | 2021/8/23 | kappa opioid receptor agonist | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations | |
| 458 | Jakafi | ruxolitinib | Single | 84:92 | 2011/11/18 | JAK inhibitor | To treat patients with the bone marrow disease myelofibrosis. | ||
| 459 | Daliresp | roflumilast | Single | 84:92 | 2011/2/28 | PDE4 inhibitor | To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). | ||
| 460 | Gemtesa | vibegron | Single | G04BD15 | 86:12 | 2021/1/21 | beta-3 adrenergic receptor agonist | To treat overactive bladder | |
| 461 | Kisunla | donanemab-azbt | Single | N06DX05 | 90:10 | 2024/7/2 | anti-amyloid-beta mab | To treat Alzheimer’s disease | |
| 462 | Piasky | crovalimab-akkz | Single | L04AJ07 | 90:20 | 2024/6/20 | complement protein C5 inhibitor | To treat paroxysmal nocturnal hemoglobinuria | |
| 463 | Bridion | sugammadex | Single | V03AB35 | 92:12 | 2015/12/22 | inactivates NMBA in plasma | To reverse effects of neuromuscular blocking drugs used during surgery | |
| 464 | Zurampic | lesinurad | Single | M04AB05 | 92:16 | 2016/2/18 | URAT1 inhibitor | To treat high blood uric acid levels associated with gout | |
| 465 | Vyondys 53 | golodirsen | Single | M09AX08 | 92:18 | 2019/12/20 | binds exon 53 of dystrophin pre-mRNA to cause exon 53 skipping | To treat certain patients with Duchenne muscular dystrophy | |
| 466 | Viltepso | viltolarsen | Single | M09AX12 | 92:18 | 2020/8/26 | antisense oligonucleotide binding to dystrophin pre-mRNA | To treat Duchenne muscular dystrophy | |
| 467 | Amondys 45 | casimersen | Single | M09AX13 | 92:18 | 2021/2/26 | antisense oligonucleotide binding dystrophin pre-mRNA exon 45 | To treat Duchenne muscular dystrophy | |
| 468 | Tegsedi | inotersen | Single | N07XX15 | 92:18 | 2018/10/24 | binds TTR mRNA and degrades it | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults | |
| 469 | Wainua | eplontersen | Single | N07XX21 | 92:18 | 2023/12/21 | antisense oligonucleotide | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | |
| 470 | Plegridy | peginterferon beta-1a | Single | L03AB13 | 92:20 | 2014/9/4 | For the treatment of patients with relapsing forms of multiple sclerosis | ||
| 471 | Joenja | leniolisib | Single | L03AX22 | 92:20 | 2023/3/24 | PI3K-delta inhibitor | To treat activated phosphoinositide 3-kinase delta syndrome | |
| 472 | Vyvgart | efgartigimod alfa-fcab | Single | L04AA58 | 92:20 | 2021/12/17 | FcRn blocker | To treat generalized myasthenia gravis | |
| 473 | Zinbryta | daclizumab | Single | L04AC01 | 92:20 | 2016/5/27 | IL-2R antagonist | To treat multiple sclerosis | |
| 474 | Enspryng | satralizumab-mwge | Single | L04AC19 | 92:20 | 2020/8/28 | IL-6 receptor inhibitor | To treat neuromyelitis optica spectrum disorder | |
| 475 | Zeposia | ozanimod | Single | L04AE02 | 92:20 | 2020/4/17 | blocks lymphocytes from egressing from lymph nodes | To treat relapsing forms of multiple sclerosis | |
| 476 | Mayzent | siponimod | Single | L04AE03 | 92:20 | 2019/4/12 | S1P receptor modulator | To treat adults with relapsing forms of multiple sclerosis | |
| 477 | Ponvory | ponesimod | Single | L04AE04 | 92:20 | 2021/4/2 | S1P receptor 1 modulator | To treat relapsing forms of multiple sclerosis | |
| 478 | Ocrevus | ocrelizumab | Single | L04AG08 | 92:20 | 2017/4/11 | mab, CD20 | To treat patients with relapsing and primary progressive forms of multiple sclerosis | |
| 479 | Uplizna | inebilizumab-cdon | Single | L04AG10 | 92:20 | 2020/6/30 | mab, CD19 | To treat neuromyelitis optica spectrum disorder | |
| 480 | Briumvi | ublituximab-xiiy | Single | L04AG14 | 92:20 | 2022/12/28 | mab, CD20 | To treat relapsing forms of multiple sclerosis | |
| 481 | Rystiggo | rozanolixizumab-noli | Single | L04AG16 | 92:20 | 2023/6/26 | neonatal Fe receptor (FcRn) binding mab | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive | |
| 482 | Tecfidera | dimethyl fumarate | Single | L04AX07 | 92:20 | 2013/5/10 | To treat adults with relapsing forms of multiple sclerosis (MS). | ||
| 483 | Evenity | romosozumab-aqqg | Single | M05BX06 | 92:22 | 2019/4/23 | sclerostin inhibitor | To treat osteoporosis in postmenopausal women at high risk of fracture | |
| 484 | Takhzyro | lanadelumab | Single | B06AC05 | 92:32 | 2018/8/30 | inhibits proteolytic activity of plasma kallikrein | To treat types I and II hereditary angioedema | |
| 485 | Orladeyo | berotralstat | Single | B06AC06 | 92:32 | 2020/12/16 | kallikrein inhibitor | To treat patients with hereditary angioedema | |
| 486 | Ultomiris | ravulizumab | Single | L04AJ02 | 92:32 | 2019/2/6 | long-acting complement C5 inhibitor | To treat paroxysmal nocturnal hemoglobinuria (PNH) | |
| 487 | Empaveli | pegcetacoplan | Single | L04AJ03, S01XA31 | 92:32 | 2021/5/23 | C3 inhibitor | To treat paroxysmal nocturnal hemoglobinuria | |
| 488 | Tavneos | avacopan | Single | L04AJ05 | 92:32 | 2021/10/7 | C5aR antagonist | To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids | |
| 489 | Zilbrysq | zilucoplan | Single | L04AJ06 | 92:32 | 2023/10/17 | complement C5 protein inhibitor | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | |
| 490 | Fabhalta | iptacopan | Single | L04AJ08 | 92:32 | 2023/12/5 | complement factor B protein inhibitor | To treat paroxysmal nocturnal hemoglobinuria | |
| 491 | Voydeya | danicopan | Single | L04AJ09 | 92:32 | 2024/3/29 | complement factor D inhibitor | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria | |
| 492 | Veopoz | pozelimab-bbfg | Single | L04AJ11* | 92:32 | 2023/8/18 | complement C5 protein inhibitor | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | |
| 493 | Otezla | apremilast | Single | L04AA32 | 92:36 | 2014/4/21 | PDE4 selective inhibitor | To treat adults with active psoriatic arthritis (PsA) | |
| 494 | Kevzara | sarilumab | Single | L04AC14 | 92:36 | 2017/6/23 | IL-6 signaling inhibitor | To treat adult rheumatoid arthritis | |
| 495 | Olumiant | baricitinib | Single | L04AF02 | 92:36 | 2018/6/25 | JAK inhibitor | To treat moderately to severely active rheumatoid arthritis | |
| 496 | Rinvoq | upadacitinib | Single | L04AF03 | 92:36 | 2019/8/21 | JAK inhibitor | To treat adults with moderately to severely active rheumatoid arthritis | |
| 497 | Lupkynis | voclosporin | Single | L04AD03 | 92:44 | 2021/2/5 | calcineurin inhibitor | To treat lupus nephritis | |
| 498 | Gamifant | emapalumab-lzsg | Single | L04AG09 | 92:44 | 2018/11/26 | binds IFNγ and blocks its signaling to inhibit macrophage activation and downstream release of proinflammatory cytokines | To treat primary hemophagocytic lymphohistiocytosis (HLH) | |
| 499 | Saphnelo | anifrolumab-fnia | Single | L04AG11 | 92:44 | 2021/7/30 | type 1 IFN signaling inhibitor | To treat moderate-to severe systemic lupus erythematousus along with standard therapy | |
| 500 | Benlysta | belimumab | Single | 92:44 | 2011/3/9 | binds BLyS and blocks its interaction with B cell receptors | To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. | ||
| 501 | Cosela | trilacicilib | Single | V03AF12 | 92:56 | 2021/2/26 | CDK4/6 inhibitor | To mitigate chemotherapy-induced myelosuppression in small cell lung cancer | |
| 502 | Cerdelga | eliglustat | Single | A16AX10 | 92:92 | 2014/9/16 | For the long-term treatment of adult patients with the Type 1 form of Gaucher disease | ||
| 503 | Xuriden | uridine triacetate | Single | A16AX13 | 92:92 | 2015/9/22 | an acetylated form of uridine that inhibits cell damage and death | To treat patients with hereditary orotic aciduria | |
| 504 | Galafold | migalastat | Single | A16AX14 | 92:92 | 2018/8/22 | stabilize body’s dysfunctional alpha-Gal A enzyme to clear disease substrate | To treat adults with Fabry disease. | |
| 505 | Givlaari | givosiran | Single | A16AX16 | 92:92 | 2019/11/25 | causes ALAS1 mRNA degradation | To treat acute hepatic porphyria, a rare blood disorder | |
| 506 | Oxlumo | lumasiran | Single | A16AX18 | 92:92 | 2020/11/25 | oxalate synthesis inhibitor | To treat hyperoxaluria type 1 | |
| 507 | Nulibry | fosdenopterin | Single | A16AX19 | 92:92 | 2021/3/2 | exogenous source of cPMP | To reduce the risk of mortality in molybdenum cofactor deficiency Type A | |
| 508 | Zokinvy | lonafarnib | Single | A16AX20 | 92:92 | 2020/11/25 | farnesyltransferase inhibitor | To treat rare conditions related to premature aging | |
| 509 | Rivfloza | nedosiran | Single | A16AX25* | 92:92 | 2023/9/29 | siRNA and LDH inhibitor | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | |
| 510 | Filspari | sparsentan | Single | C09XX01 | 92:92 | 2023/2/17 | endothelin type A receptor and angiotensin II type 1 receptor antagonist | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | |
| 511 | Kybella | deoxycholic acid | Single | D11AX24 | 92:92 | 2015/6/22 | causes adipocytes lysis | To treat adults with moderate-to-severe fat below the chin, known as submental fat | |
| 512 | Isturisa | osilodrostat | Single | H02CA02 | 92:92 | 2020/4/10 | 11-beta- hydroxylase enzyme inhibitor | To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease | |
| 513 | Parsabiv | etelcalcetide | Single | H05BX04 | 92:92 | 2017/2/15 | binds CaSR to enhance activation of receptor by extracellular Ca | To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis | |
| 514 | Rezurock | belumosudil | Single | L04AA48 | 92:92 | 2021/7/16 | ROCK 2 pathway blocker | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy |