Table 1.
Some examples of protein-based parenteral dosage forms approved by the FDA.
| Year | Active Ingredient Trade Name |
Description | Pharmaceutical Dosage Form | Indication |
|---|---|---|---|---|
| 2017 | Etelcalcetide Parsabiv® |
Calcium-sensing receptor agonist | Injectable solution (IV) | Hyperparathyroidism |
| 2017 | Semaglutide Ozempic® |
Glucagon-like peptide 1 (GLP-1) receptor agonist | Injectable solution (SC) | Diabetes |
| 2018 | Tildrakizumab Ilumya® |
Interleukin-23 antagonist | Injectable solution (SC) | Moderate-to-severe plaque psoriasis |
| 2018 | Cemiplimab Libtayo® |
Programmed death receptor-1 (PD-1) blocking antibody | Injectable solution (IV) | Cutaneous squamous-cell carcinoma |
| 2018 | Calaspargase pegol Asparlas® |
Asparagine-specific enzyme | Injectable solution (IV) | Acute lymphoblastic leukemia |
| 2019 | Crizanlizumab-tmca Adakveo® |
Selectin-blocking antibody | Injectable solution (IV) | Pain caused by sickle cell disease |
| 2020 | Setmelanotide ImcivreeTM |
Melanocortin 4 (MC4) receptor agonist | Injectable solution (SC) | Chronic weight management |
| 2020 | Somapacitan-beco Sogroya® |
Human growth hormone analog | Injectable solution (SC) | Growth hormone deficiency |
| 2020 | Ansuvimab-zykl EbangaTM |
Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody | Injectable solution (IV) | Infection caused by Zaire ebolavirus |
| 2021 | Dasiglucagon Zegalogue® |
Anti-hypoglycemic agent | Injectable solution (SC) | Severe hypoglycemia |
| 2021 | Dostarlimab-gxly Jemperli® |
Programmed death receptor-1 (PD-1) blocking antibody | Injectable solution (IV) | Endometrial cancer |
| 2022 | Olipudase alfa XenpozymeTM |
Sphingomyelin-specific enzyme | Injectable solution (IV) | Acid sphingomyelinase deficiency |
| 2023 | Pegunigalsidase alfa-iwxj Elfabrio® |
Glycosphingolipid-specific enzyme | Injectable solution (IV) | Fabry disease |
| 2023 | Somatrogon-ghla NgenlaTM |
Human growth hormone analog | Injectable solution (SC) | Growth hormone deficiency |
| 2023 | Pozelimab-bbfg VeopozTM |
Recombinant IgG4 monoclonal antibody | Injectable solution (IV or SC) | CHAPLE disease |
CHAPLE: CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy; IV: intravenous; SC: subcutaneous.