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Term for a groundbreaking pharmaceutical drug
A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food
First-in-class_medication
Medication
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Zanidatamab is indicated for the treatment of adults with previously
Zanidatamab
Medication
Vyvgart, is a medication used to treat myasthenia gravis. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication. It is an antibody
Efgartigimod_alfa
Medication
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Omaveloxolone is indicated for the treatment of Friedreich's
Omaveloxolone
Chemical compound
in the US in March 2024, and in the European Union in August 2025. The US Food and Drug Administration considers it to be a first-in-class medication
Resmetirom
Medication used to treat pulmonary arterial hypertension
Sotatercept, sold under the brand name Winrevair, is a medication used to treat pulmonary arterial hypertension. It inhibits activin signaling using the
Sotatercept
Medication
for medical use in the United States in October 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Nerandomilast
Nerandomilast
Medication used to treat chronic spontaneous urticaria
considers it to be a first-in-class medication. Remibrutinib is indicated for the treatment of chronic spontaneous urticaria in adults who remain symptomatic
Remibrutinib
Medication for dry eye disease
in the United States in May 2023 under the brand name Miebo. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication
Perfluorohexyloctane
Cholesterol-lowering medication
considers it to be a first-in-class medication. In the US, bempedoic acid is indicated for the treatment of hypercholesterolemia in combination with diet
Bempedoic_acid
Chemical compound
Administration considers it to be a first-in-class medication. Elamipretide is indicated to improve muscle strength in people with Barth syndrome weighing
Elamipretide
Pharmaceutical drug
medical use in the United States in April 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Mavacamten is
Mavacamten
Medication
The FDA considers it to be a first-in-class medication. Levacetylleucine is the first treatment approved for ataxia in people with ataxia-telangiectasia
Levacetylleucine
Non-opioid analgesic drug
for medical use in the United States in January 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Suzetrigine is
Suzetrigine
Medication for low blood pressure
a first-in-class medication. It is approved as a generic medication. Angiotensin II is a vasoconstrictor used to increase blood pressure in adults with
Angiotensin_II_(medication)
Antiretroviral medication
The FDA considers it to be a first-in-class medication. In 2025, lenacapavir was approved for HIV prevention (PrEP) in the United States, the European
Lenacapavir
Medication
for medical use in the United States in August 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Rilzabrutinib
Rilzabrutinib
Pharmaceutical compound
medical use in the United States in December 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Crinecerfont
Crinecerfont
Medication
approved for medical use in the US and EU. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Common side effects include
Tofersen
Monoclonal antibody
considers it to be a first-in-class medication. Nemolizumab is indicated for the treatment of adults with prurigo nodularis. In December 2024, the indication
Nemolizumab
Chemical compound
Iptacopan, sold under the brand name Fabhalta, is a medication used for the treatment of paroxysmal nocturnal hemoglobinuria and proteinuria. It is a complement
Iptacopan
Monoclonal antibody
in September 2024, and in the United States in October 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication
Zolbetuximab
Medication
considers it to be a first-in-class medication. The drug was approved for the treatment of focal segmental glomerulosclerosis in April 2026. Sparsentan
Sparsentan
Medication
for medical use in the United States in April 2024. The US Food and Drug Administration considers it to be a first-in-class medication. Nogapendekin alfa
Nogapendekin_alfa_inbakicept
Monoclonal antibody
for medical use in the United States in May 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Tarlatamab is
Tarlatamab
Chemical compound
considers it to be a first-in-class medication. Brensocatib is indicated for the treatment of non-cystic fibrosis bronchiectasis in people aged twelve years
Brensocatib
Pharmaceutical drug
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Romosozumab is used for osteoporosis to decrease the risk of
Romosozumab
Pharmaceutical compound
cancer when used in combination with fulvestrant. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. In April 2025 capivasertib
Capivasertib
Medication
a first-in-class medication. Danicopan is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis in adults
Danicopan
Antibacterial drug
medical use in the United States in March 2025. The US Food and Drug Administration considers it to be a first-in-class medication. It is the first triazaacenaphthylene
Gepotidacin
Medication
long been the standard of care. The FDA considers it to be a first-in-class medication. Trospium chloride is a peripherally selective non-selective muscarinic
Xanomeline/trospium_chloride
Medication
for medical use in the United States in December 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Narsoplimab is
Narsoplimab
Monoclonal antibody
considers it to be a first-in-class medication. Inebilizumab is indicated for the treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4
Inebilizumab
Chemical compound
Food and Drug Administration (FDA). The FDA considers it to be a first-in-class medication. Dordaviprone is indicated for the treatment of people with diffuse
Dordaviprone
Medication
approved in the United States in June 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Garadacimab is indicated for
Garadacimab
Medication
harboring an neuregulin 1 gene fusion. The FDA considers it to be a first-in-class medication. Zenocutuzumab is indicated for the treatment of adults with advanced
Zenocutuzumab
Pharmaceutical drug
approved for medical use in the United States. The U.S. Food and Drug Administration considers it to be a first-in-class medication. In August 2023, the National
Inclisiran
Medication used to treat paroxysmal nocturnal hemoglobinuria
medical use in the United States in May 2021. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. In 2024, the American
Pegcetacoplan
Medication
for medical use in the United States in March 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Fitusiran is indicated
Fitusiran
Monoclonal antibody
use in both the United States and the European Union in August 2023. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication
Talquetamab
Pharmaceutical drug
protein in the liver via the RNAi pathway. Patisiran was developed and is marketed by Alnylam. The FDA considers it to be a first-in-class medication. Patisiran
Patisiran
Medication
medication for the treatment of activated PI3K delta syndrome. The US Food and Drug Administration considers it to be a first-in-class medication. In
Leniolisib
Chemical compound
novel; therefore, if approved, fosmanogepix would become a first-in-class medication. In 2023, the drug was given a compassionate use authorization for
Fosmanogepix
Medication
medical use in the United States in January 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Berdazimer
Berdazimer_sodium
Chemical compound
The FDA considers it to be a first-in-class medication. Aprocitentan is indicated for the treatment of hypertension in combination with other antihypertensive
Aprocitentan
Pharmaceutical drug
medical use in the United States in January 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Tebentafusp
Tebentafusp
Medication
U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Enfortumab vedotin is indicated for the treatment of adults with
Enfortumab_vedotin
Medication investigated as a treatment for progeria
S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Lonafarnib is indicated to be used to reduce the risk of death due
Lonafarnib
Chelate of Lu-177 with dotatate, a peptide derivative bound to a DOTA molecule
177Lu dotatate to be a first-in-class medication. In September 2026, the FDA approved the radioligand equivalent Bexlutry. In the US, 177Lu dotatate is
Lutetium (177Lu) oxodotreotide
Lutetium_(177Lu)_oxodotreotide
Medication
for medical use in the United States in November 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Plozasiran is
Plozasiran
Chemical compound
for medical use in the United States in December 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Zoliflodacin
Zoliflodacin
Chemical compound
considers it to be a first-in-class medication. Edaravone is used to help people recover from stroke in Japan, and is used to treat ALS in the US and Japan
Edaravone
Radiopharmaceutical medication
The US Food and Drug Administration considers it to be a first-in-class medication. Lutetium (177Lu) vipivotide tetraxetan is indicated for the treatment
Lutetium (177Lu) vipivotide tetraxetan
Lutetium_(177Lu)_vipivotide_tetraxetan
Experimental drug for the treatment of achondroplasia
considers it to be a first-in-class medication. In the European Union, vosoritide is indicated for the treatment of achondroplasia in people two years of age
Vosoritide
Medication
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Pozelimab is indicated for the treatment of people with CD55-deficient
Pozelimab
Chemical compound
medical use in the United States in November 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Revumenib
Revumenib
Medication for transthyretin amyloidosis
Administration considers tafamidis to be a first-in-class medication. Tafamidis is used to delay nerve damage in adults who have transthyretin amyloidosis
Tafamidis
Chemical compound
medical use in the United States in April 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Mavorixafor
Mavorixafor
Chemical compound
for medical use in the United States in October 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Elinzanetant is
Elinzanetant
Chemical compound
to be a first-in-class medication. Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. In September
Fezolinetant
Chemical compound
invasive mold infections. If approved it would be a first-in-class medication (for the orotomide class). In 2023, the FDA decided not to approve the drug and
Olorofim
Monoclonal antibody
U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. It is on the World Health Organization's List of Essential Medicines
Emicizumab
Drug used to treat allergic diseases
atopic dermatitis in 2017, and for asthma in 2018. The FDA considers it to be a first-in-class medication. Dupilumab is the first treatment for eosinophilic
Dupilumab
Chemical compound
States in July 2021, and in the European Union in February 2022. The US Food and Drug Administration considers it to be a first-in-class medication. In the
Finerenone
Chemical compound
Food and Drug Administration (FDA). The FDA considers it to be a first-in-class medication. Since early 2026, avacopan has been reported to have severe side
Avacopan
Pharmaceutical compound
neuroprotective agent against demyelination and is said to be a potential first-in-class medication. The pharmacokinetics of Lucid-MS have been described. It was
Lucid-MS
Antibody-drug conjugate
for medical use in the United States in May 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Telisotuzumab vedotin
Telisotuzumab_vedotin
Medication
a first-in-class medication. Marstacimab is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people aged
Marstacimab
Anti-diabetic and anti-obesity medication
Administration (FDA) considers it a first-in-class medication. The FDA approved it for weight loss in November 2023. Also in November 2023, the UK Medicines
Tirzepatide
Medication
Administration considers it to be a first-in-class medication. In December 2021, voxelotor received accelerated approval in the United States for the treatment
Voxelotor
Anti-CD20 monoclonal antibody
US Food and Drug Administration (FDA) considers it to be a first-in-class medication. In the US, ocrelizumab is indicated for the treatment of relapsing
Ocrelizumab
Chemical compound
medical use in the United States in July 2023. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Lotilaner is
Lotilaner
Chemical compound
for medical use in the United States in May 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Tapinarof is
Tapinarof
Chemical compound
Rezurock among others, is a medication used for the treatment of chronic graft versus host disease (cGvHD). It is in the class of drugs known as serine/threonine
Belumosudil
Combination medication
considers it to be a first-in-class medication. Doxecitine/doxribtimine is indicated for the treatment of thymidine kinase 2 deficiency in people with an age
Doxecitine/doxribtimine
Chemical compound
for medical use in the United States in 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Terlipressin is
Terlipressin
Monoclonal antibody
the European Union in September 2022. The US Food and Drug Administration (FDA) considered it 2021 to be a first-in-class medication. Tezepelumab is indicated
Tezepelumab
Monoclonal antibody
to be a first-in-class medication. Satralizumab is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular
Satralizumab
Monoclonal antibody
medical use in the United States in August 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Axatilimab
Axatilimab
Chemical compound
Lumykras, is an anti-cancer medication used to treat non-small-cell lung cancer. It targets a specific mutation, G12C, in the protein K-Ras encoded by
Sotorasib
Antiviral drug
considers it to be a first-in-class medication. In the European Union, remdesivir is indicated for the treatment of COVID‑19 in adults and adolescents
Remdesivir
Medication
for medical use in the United States in November 2025. The US Food and Drug Administration considers it to be a first-in-class medication. Sibeprenlimab
Sibeprenlimab
Fluorescent drug
medical use in the United States in November 2021. The U.S. Food and Drug Administration considers it to be a first-in-class medication. Pafolacianine
Pafolacianine
Antiviral drug
disease in recipients of an allogeneic stem cell transplant. The FDA considers it to be a first-in-class medication. In the US as well as in the EU, letermovir
Letermovir
Class of pharmaceutical drugs
class of drugs developed to treat heart failure, pulmonary hypertension, and other diseases. The first-in-class medication was riociguat, approved in
Soluble guanylate cyclase stimulator
Soluble_guanylate_cyclase_stimulator
Viral infection of the skin
medical use in the United States in January 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Imiquimod is
Molluscum_contagiosum
Monoclonal antibody
U.S. Food and Drug Administration considers it to be a first-in-class medication. In systemic lupus erythematosus, the body can produce a great amount
Anifrolumab
Blood disease in which red blood cells are attacked by the immune system
medical use in the United States in May 2021. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. In 2024, the American
Paroxysmal nocturnal hemoglobinuria
Paroxysmal_nocturnal_hemoglobinuria
Chemical compound
medical use in the United States in July 2020. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Abametapir
Abametapir
Pharmaceutical drug
Administration (FDA) considers it to be a first-in-class medication. It was approved for use in the European Union in August 2018. Mepsevii is indicated for
Vestronidase_alfa
Medication
medical use in the United States in September 2023. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Primary hyperoxaluria
Nedosiran
Pharmaceutical drug
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Luspatercept is indicated for the treatment of adults with
Luspatercept
Monoclonal antibody
US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Mosunetuzumab is indicated for the treatment of adults with relapsed
Mosunetuzumab
Monoclonal antibody
August 2022, and in the United States in October 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Teclistamab
Teclistamab
Medication
for medical use in the United States in December 2024. The US Food and Drug Administration considers it to be a first-in-class medication. Olezarsen is
Olezarsen
Chemical compound
Palovarotene, sold under the brand name Sohonos, is a medication used for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva
Palovarotene
Pharmaceutical drug
and Drug Administration (FDA) considers it to be a first-in-class medication. Tafasitamab, in combination with lenalidomide, is indicated for the treatment
Tafasitamab
Chemical compound
to be a first-in-class medication. Midostaurin was found to be active against oncogenic CD135 (FMS-like tyrosine kinase 3 receptor, FLT3), in preclinical
Midostaurin
Chemical compound
first-in-class medication. Setmelanotide is indicated for chronic weight management (weight loss and weight maintenance for at least one year) in people
Setmelanotide
Chemical compound
2021. The U.S. Food and Drug Administration considers it to be a first-in-class medication. Chemotherapy drugs are designed to kill cancer cells but can
Trilaciclib
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FIRST IN-CLASS-MEDICATION
FIRST IN-CLASS-MEDICATION
FIRST IN-CLASS-MEDICATION
FIRST IN-CLASS-MEDICATION
FIRST IN-CLASS-MEDICATION
FIRST IN-CLASS-MEDICATION
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