Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Mar 5;13(3):40.
doi: 10.3390/ph13030040.

2019 FDA TIDES (Peptides and Oligonucleotides) Harvest

Danah Al Shaer  1   2 , Othman Al Musaimi  1   2 , Fernando Albericio  2   3 , Beatriz G de la Torre  1
Affiliations
Review

2019 FDA TIDES (Peptides and Oligonucleotides) Harvest

Danah Al Shaer et al. Pharmaceuticals (Basel). .

Abstract

2019 has been an excellent year in terms of peptides and oligonucleotides (TIDES) approved by the FDA. Despite the drop in the number of total drugs approved by the FDA in 2019 in comparison with 2018 (48 vs. 59), the total number of TIDES authorized increased (seven vs. three). Year after year, TIDES are increasingly present in therapy, as imaging agents, theragnostic and constituent moieties of other complex drugs, such as antibody drug conjugates. This means a consolidation of these kinds of drugs in the pharmaceutical arena, paving the way in the coming years for the approval of others for diverse medical indications. Here the TIDES approved in 2019 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

Keywords: 68Ga-DOTATOC; DOTATOC; afamelanotide; bremelanotide; drugs; enfortumab vedotin; givosiran; golodirsen; oligonucleotides; peptides; pharmaceutical market; polatuzumab vedotin.

PubMed Disclaimer

Conflict of interest statement

References

Figures

Figure 1
Figure 1
A total of 175 new drugs approved by the FDA from 2016 to 2019 [1,2,3,4]. mAbs; Monoclonal antibodies, ADCs; antibody drug conjugates, Oligos; oligonucleotides.
Figure 2
Figure 2
Chemical structure of golodersin (Vyondys 53TM).
Figure 3
Figure 3
Chemical structure of givosiran (GivlaariTM) [13].
Figure 4
Figure 4
Chemical structure of 68Ga-DOTATOC.
Figure 5
Figure 5
Chemical structure of: (A) Afamelanotide (ScenesseTM); (B) α-melanocyte stimulating hormone (α-MSH). Differences are shown in red.
Figure 6
Figure 6
Chemical structure of bremelanotide (VyleesiTM).
Figure 7
Figure 7
Chemical structure of enfortumab vedotin-ejfv (PadcevTM) and polatuzumab vedotin-piiq (PolivyTM). MMAE; monomethyl auristatin E.
Figure 8
Figure 8
Chemical structure of: (A) Synthetic monomethyl auristatin E (MMAE) analogue; (B) natural dolastatin 10. Differences are shown in red [50].
Figure 9
Figure 9
Mechanism of payload release in ADCs with Val-Cit linker and p-aminobenzyl carbamate as a spacer [67]. MMAE; monomethyl auristatin E.
Figure 10
Figure 10
Chemical structure of fam-trastuzumab deruxtecan-nxki (EnhertuTM) showing the tetrapeptide linker and amino methylene cleavage in the payload-release process. AM; aminomethyl.
See this image and copyright information in PMC

References

    1. de la Torre B.G., Albericio F. The pharmaceutical industry in 2016. An analysis of FDA drug approvals from a perspective of the molecule type. Molecules. 2017;22 doi: 10.3390/molecules22030368. - DOI - PMC - PubMed
    1. de la Torre B.G., Albericio F. The pharmaceutical industry in 2017. An analysis of FDA drug approvals from the perspective of molecules. Molecules. 2018;23 doi: 10.3390/molecules23030533. - DOI - PMC - PubMed
    1. de la Torre B.G., Albericio F. The pharmaceutical industry in 2018. An analysis of FDA drug approvals from the perspective of molecules. Molecules. 2019;24 doi: 10.3390/molecules24040809. - DOI - PMC - PubMed
    1. de la Torre B.G., Albericio F. The pharmaceutical industry in 2019. An analysis of FDA drug approvals from the perspective of molecules. Molecules. 2020;25:745. doi: 10.3390/molecules25030745. - DOI - PMC - PubMed
    1. New Drug Therapy Approvals 2019. [(accessed on 27 February 2020)];2019 Available online: https://www.fda.gov/media/134493/download.

LinkOut - more resources