Table 1.
Summary of the 2020 FDA peptides and oligonucleotides (TIDES) harvest.
| # | Active Ingredient (Trade Name) | Type | Indication | Target | Route |
|---|---|---|---|---|---|
| 1 | Viltolarsen (ViltepsoTM) | Antisense oligonucleotide |
Duchenne’s muscular dystrophy (DMD) | DMD Exon 53 | Intravenous |
| 2 | Lumasiran (OxlumoTM) |
Antisense oligonucleotide |
Primary hyperoxaluria type 1 (PH1) |
Hydroxyacid oxidase (glycolate oxidase) 1 (HOA1) mRNA | Subcutaneous |
| 3 | Setmelanotide (ImcivreeTM) | Peptide | Chronic weight management (obesity) |
Melanocortin-4 receptor (MC4R) |
Subcutaneous |
| 4 | 64Cu-DOTATATE (DetectnetTM) | Peptide | Scintigraphic imaging | Somatostatin receptor | Intravenous |
| 5 | 68Ga-PSMA-11 | Peptide | Diagnosis of recurrent prostate carcinoma | Prostate-specific membrane antigen (PSMA) |
Intravenous |
| 6 | Belantamab mafodotin-blmf (BlenrepTM) | ADC a with peptide payload | Relapsed or refractory multiple myeloma | B-cell maturation antigen (BCMA) |
Intravenous |
a ADC, antibody drug conjugate.