A Compilation of Investigational, Preclinical and Clinical Enzyme Based Therapeutics

Published: 6 May 2021| Version 1 | DOI: 10.17632/mbpf96y497.1
Michael Lynch


A compiled list of Investigational, Preclinical and Clinical Enzyme Based Therapeutics, included within 4 Tables Table 1: Enzyme based therapeutics by class & challenges to clinical use Table 2: All FDA Approved Protein based therapeutics , 1965-2020 Table 3: FDA Approved Enzyme based therapeutics , 1965-2020 Table 4: Early Investigational Enzyme based therapeutics


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Method for data collection and analysis: FDA approved proteins were downloaded from THPdb1. Only proteins from group I and II pharmacological classifications underwent further analysis since group III and IV are used in vaccines and diagnostic agents which are outside the scope of this review2. FDA approvals between 2018 and 2020 were gathered from the literature and cross referenced with the FDA website which was also used to determine the year of each BLA3–6. Any proteins that have been withdrawn since their initial approval were removed. Additional formulations of the same enzyme (based on amino acid sequence) such as pegylated variants were excluded, however altered amino acid sequences were considered a different EBT. All protein based therapeutics used to make Figure 2C and the year of FDA approval is listed in supplemental table 2. All FDA approved EBTs are listed in supplemental table 3. EBTs used prior to FDA approval were gathered based on literature searches for EBT publications prior to 1962. Each early EBT used to make Figure 2A is listed and referenced in supplemental table 4. References: 1. Usmani, S. S. et al. THPdb: Database of FDA-approved peptide and protein therapeutics. PLoS One 12, e0181748 (2017). 2. Leader, B., Baca, Q. J. & Golan, D. E. Protein therapeutics: a summary and pharmacological classification. Nat. Rev. Drug Discov. 7, 21–39 (2008). 3. Mullard, A. 2018 FDA drug approvals. Nat. Rev. Drug Discov. 18, 85–89 (2019). 4. Mullard, A. 2019 FDA drug approvals. Nat. Rev. Drug Discov. 19, 79–84 (2020). 5. Mullard, A. 2020 FDA drug approvals. Nat


Duke University


Health Sciences