5 minute read
Jun. 6, 2021

2020 Small Molecule Drug Approvals

drughunter.com
Drug Hunter Team

On Jun. 23rd at 11AM PST, Dewakar Sangaraju and Dennis Hu gave a PBSS/CLSA webinar titled “Highlights from 2020’s FDA New Drug Approvals,” organized by Cyrus Khojasteh and Shichang Miao. One interesting fact about each approved small molecule drug was shared, along with statistics and specific case studies from the cohort of interest to the audience.

Subscribers can get a complete visual list with the structures of 2020 FDA new drug approvals by contacting info@drughunter.com. 2020’s large molecule FDA new drug approvals can be found here. The list of 2020 FDA approved drugs also contains drug route of administration, mechanism of action, dosing, main trial outcome or primary endpoint, NCT trial #’s for pivotal trials (Ph. III unless otherwise specified), number of patients enrolled in the pivotal trials at the time of approval, specialty and indication, all summarized from the FDA drug labels or clinical trial entries linked below. There is no meaning to the order in which drugs are presented.

Disclaimer: This information is shared for educational purposes only, is intended for research professionals, is not medical advice, is not shared on behalf of any of the contributors’ employers, and is not an endorsement of any of these products. Complete safety information can be found in each drug’s FDA label.

List of 2020 Small Molecule Drug Approvals

  1. Zeposia (ozanimod) – oral S1P(1/5) receptor modulator – NCT02294058NCT02047734 

  2. Nurtec ODT (rimegepant) – oral CGRP GPCR antagonist – NCT03461757 

  3. Tazverik (tazemetostat  – oral EZH2 methyltransferase inhibitor – NCT02601950 

  4. Retevmo (selpercatinib) – oral RET fusion kinase inhibitor (WT+mut) – NCT03157128 

  5. Rukobia (fostemsavir) –  oral HIV-1 gp120 attachment inhibitor – NCT02362503 

  6. Veklury (remdesivir) – IV nucleotide RNA polymerase inhibitor – NCT04280705NCT04292899NCT04292730

  7. Orladeyo (berotralstat) – oral plasma kallikrein inhibitor – NCT3485911 

  8. Inqovi (decitabine and cedazuridine) – oral nucleoside cytidine deaminase inhibitor – NCT02103478 NCT03306264

  9. Gemtesa (vibegron) –  oral selective β3 adrenergic receptor agonist – NCT03492281

  10. Zokinvy (lonafarnib)-  oral farnesyltransferase inhibitor – NCT00425607 ; NCT00916747 

  11. Ongentys (opicapone)- oral COMT enzyme inhibitor – NCT01568073NCT01227655 

  12. Koselugo (selumetinib) –  oral MEK1/2 kinase inhibitor – NCT01362803

  13. Zepzelca (lurbinectedin) –  IV DNA alkyating agent – NCT02454972 

  14. Orgovyx (relugolix) – oral GnRH hormone receptor antagonist – NCT03085095

  15. Evrysdi (risdiplam)- oral SMN RNA splicing modifier – NCT02913482NCT02908685 

  16. Byfavo (remimazolam) – IV GABAA receptor modulator – NCT02290873NCT02296892NCT02532647 

  17. Olinvyk (oliceridine)  – IV opioid receptor agonist  – NCT02820324 

  18. Ayvakit (avapritinib)  – oral PDGFRA + KIT kinase inhibitor – NCT02508532 

  19. Tabrecta (capmatinib) – oral MET kinase inhibitor – NCT02414139 

  20. Gavreto (pralsetinib) – oral RET fusion kinase inhibitor (WT+mut) – NCT03037385 

  21. Pemazyre (pemigatinib) – oral FGFR1/2/3 kinase inhibitor – NCT02924376 

  22. Qinlock (ripretinib) – oral KIT + PDGFRA kinase inhibitor – NCT03353753 

  23. Tukysa (tucatinib) – oral HER2 kinase inhibitor – NCT02614794 

  24. Isturisa (osilodrostat) – oral cortisol synthesis inhibitor – NCT02180217 

  25. Winlevi (clascoterone) – topical androgen receptor inhibitor – NCT02608450NCT02608476 

  26. Klisyri (tirbanibulin) – topical microtubule inhibitor – NCT03285477NCT03285490 

  27. Nexletol (bempedoic acid)  – oral ATP citrate synthase enzyme inhibitor –  NCT02666664NCT02991118 

  28. Xeglyze (abametapir) – topical metalloproteinase inhibitor – NCT02060903 NCT02062060 

  29. Tauvid (flortaucipir F18) – IV tau protein aggregate radiodiagnostic  – NCT02516046NCT03901092 

  30. Detectnet (copper Cu 64 dotatate injection) – IV somatostatin rcpt. (SSTR2) radiodiagnostic – NCT04334837 

  31. Cerianna (fluoroestradiol F18)  – IV ER-binding radiodiagnostic – NCT01986569

  32. Gallium 68 (Gallium 68 PSMA-11) – IV PSMA-binding radiodiagnostic – NCT02919111NCT02918357 

  33. Artesunate (artesunate) – IV artemisinin-based antimalarial

  34. Lampit (nifurtimox) – oral antiprotozoal – NCT02625974

  35. Pizensy (lactitol)  – oral osmotic laxative – NCT02819297NCT02481947 

  36. Dojolvi (triheptanoin) – oral fatty acid replacement

  37. Imcivree (Setmelanotide) –  subcutaneous MC4 receptor agonist – NCT02896192NCT03287960 

  38. Barhemsys (amisulpride) – IV selective dopamine D2/3 receptor antag. – NCT01991860NCT02337062 

List of Novel APIs Among FDA Drug Approvals in 2020 (Formatted Without Links)

  • ozanimod (Zeposia) – oral S1P1/5 receptor modulator

  • rimegepant (Nurtec ODT) – oral CGRP GPCR antagonist

  • tazemetostat (Tazverik) – oral EZH2 methyltransferase inhibitor

  • selpercatinib (Retevmo) – oral RET fusion kinase inhibitor (WT + mutant)

  • fostemvasir (Rukobia) – oral HIV-1 gp120 attachment inhibitor

  • remdesivir (Veklury) – IV nucleotide RNA polymerase inhibitor

  • berotralstat (Orladeyo) – oral plasma kallikrein inhibitor

  • cedazuridine (Inqovi) – oral nucleoside cytidine deaminase inhibitor

  • vibegron (Gemtesa) – oral selective B3 adrenergic receptor agonist

  • Ionafarnib (Zokinvy) – oral farnesyltransferase inhibitor

  • opicapone (Ongentys) – oral COMT enzyme inhibitor

  • selumetinib (Koselgo) – oral MEK1/2 kinase inhibitor

  • lurbinectedin (Zepelca) – IV DNA alkylating agent

  • relugolix (Orgovyx) – oral GnRH hormone receptor antagonist

  • risdiplam (Evrysdi) - oral SMN RNA splicing modifier

  • remimazolam (Byfavo) - IV GABAA receptor modulator

  • oliceridine (Olinvyk) - IV opioid receptor agonist

  • avapritinib (Ayvakit) - oral PDGFRA + KIT kinase inhibitor

  • capmatinib (Tabrecta) - oral MET kinase inhibitor

  • pralsetinib (Gavreto) - oral RET fusion kinase inhibitor (WT+mut)

  • pemigatinib (Pemazyre) - oral FGFR1/2/3 kinase inhibitor

  • ripretinib (Qinlock) - oral KIT + PDGFRA kinase inhibitor

  • tucatinib (Tukysa) - oral HER2 kinase inhibitor

  • osildrostat (Isturisa) - oral cortisol synthesis inhibitor

  • clascoterone (Winlevi) - topical androgen receptor inhibitor

  • tirbanibulin (Klisyri) - topical microtubule inhibitor

  • bempedoic acid (Nexletol) - oral ATP citrate synthase enzyme inhibitor

  • abametapir (Xeglyze) - topical metalloproteinase inhibitor

  • flortaucipir F18 (Tauvid) - IV tau protein aggregate radiodiagnostic

  • 64Cu dotatate (Detectnet) - IV somatostatin rcpt. (SSTR2) radiodiagnostic

  • fluoroestradiol 18F (Cerianna) - IV ER-binding radiodiagnostic

  • 68Ga PSMA-11 - IV PSMA-binding radiodiagnostic

  • artesunate (Artesunate) - IV artemisinin-based antimalarial

  • nifurtimox (Lampit) - oral antiprotozoal

  • lactitol (Pizensy) - oral osmotic laxative

  • triheptanoin (Dojolvi) - oral fatty acid replacement

  • amisulpride (Barhemsys) - IV selective dopamine D2/3 receptor antagonist

  • setmelanotide (Imcivree) - subcutaneous MC4 receptor agonist

More details will be shared after the webinar on Jun. 23rd. Explore drughunter.com for more drug discovery articles.


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