Oteseconazole Explained

Tradename:Vivjoa
Dailymedid:Oteseconazole
Routes Of Administration:By mouth
Class:Antifungal
Atc Prefix:J02
Atc Suffix:AC06
Legal Us:Rx-only
Legal Us Comment:[1]
Cas Number:1340593-59-0
Pubchem:77050711
Drugbank:DB13055
Chemspiderid:52083215
Unii:VHH774W97N
Kegg:D11785
Chebi:188153
Chembl:3311228
Synonyms:VT-1161
Iupac Name:(2R)-2-(2,4-Difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol
C:23
H:16
F:7
N:5
O:2
Smiles:C1=CC(=CC=C1C2=CN=C(C=C2)C([C@](CN3C=NN=N3)(C4=C(C=C(C=C4)F)F)O)(F)F)OCC(F)(F)F
Stdinchi:1S/C23H16F7N5O2/c24-16-4-7-18(19(25)9-16)21(36,11-35-13-32-33-34-35)23(29,30)20-8-3-15(10-31-20)14-1-5-17(6-2-14)37-12-22(26,27)28/h1-10,13,36H,11-12H2/t21-/m0/s1
Stdinchikey:IDUYJRXRDSPPRC-NRFANRHFSA-N

Oteseconazole, a novel orally bioavailable and selective inhibitor of fungal cytochrome P450 enzyme 51 (CYP51), has shown promising efficacy in the treatment of recurrent vulvovaginal candidiasis (RVVC) in patients.[2] [3]

Marketed under the brand name Vivjoa, this medication was developed by Mycovia Pharmaceuticals and received approval for medicinal use from United States Food and Drug Administration (US FDA) in April 2022.[4] [5]

Society and culture

Names

Oteseconazole is the international nonproprietary name (INN).[6]

Mechanism of action

Oteseconazole targets cytochrome P450 enzymes 51 (CYP51), which a play crucial role in maintaining the integrity and growth of fungal cell membranes. Through inhibition of these enzymes, oteseconazole prevents the synthesis of ergosterol, a key component of fungal cell membranes development. This disruption in ergosterol production leads to fungal membranes permeability, ultimately causing cell death.[7]

Oteseconazole exhibits selective inhibition of fungal CYP51 and has shown remarkable potency against Candida species during in vitro pharmacological studies.[8] This targeted action of oteseconazole makes it a highly effective choice for treating RVVC.[9] Additionally, oteseconazole was found to possess superior activity against certain fungi, such as Candida glabrata compared to commonly used antifungals.[10]

Adverse effect and interaction

Oteseconazole has exhibited an outstanding tolerability profile and a low occurrence of adverse effects in clinical trials. In a phase 3 study, the incidence of treatment-emergent adverse events (TEAEs) was comparable between the oteseconazole and fluconazole/placebo groups, with the majority of TEAEs being of mild or moderate severity. No serious adverse events related to the drug, as well as no adverse effects on liver function or QT intervals, were reported. However, as with any medication, there is a potential risk of adverse effects. Therefore, it is crucial to consult with a healthcare provider prior to initiating oteseconazole or any other medication.

There is currently limited information available on oteseconazole interactions with other medications. The prescribing information for oteseconazole indicates that it is a moderate inhibitor of the CYP3A4 enzyme, suggesting that it may potentially increase the exposure of co-administered medications that are primarily metabolized by CYP3A4. Therefore, patients who are taking medications metabolized by CYP3A4 should be closely monitored for any signs of toxicity or adverse effects when using oteseconazole. It is crucial to have a discussion with a healthcare provider about the use of any medications or supplements to ensure safe and effective usage.

External links

Notes and References

  1. Web site: Vivjoa- oteseconazole capsule . DailyMed . U.S. National Library of Medicine . 12 July 2022 . 21 January 2023.
  2. Sobel JD, Nyirjesy P . Oteseconazole: an advance in treatment of recurrent vulvovaginal candidiasis . Future Microbiology . 16 . 18 . 1453–1461 . December 2021 . 34783586 . 10.2217/fmb-2021-0173 . 244131114 . free .
  3. De SK . Oteseconazole: First Approved Orally Bioavailable and Selective CYP51 Inhibitor for the Treatment of Patients with Recurrent Vulvovaginal Candidiasis . Current Medicinal Chemistry . 30 . 37 . 4170–4175 . 2023 . 36803759 . 10.2174/0929867330666230220130024 . 257066627 .
  4. Web site: Drugs@FDA: FDA-Approved Drugs . 2023-06-26 . www.accessdata.fda.gov . en.
  5. Web site: 2022-04-28 . FDA Approves Mycovia Pharmaceuticals' VIVJOA™ (oteseconazole), the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection) . 2023-06-26 . www.businesswire.com . en.
  6. ((World Health Organization)) . 2016 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76 . WHO Drug Information . 30 . 3 . 10665/331020 . free . World Health Organization .
  7. Treating recurrent vulvovaginal candidiasis . OBG Manag . November 2022 . 34 . 11 . 22-24, 28-30, 32 . 10.12788/obgm.0238 . Butler SK, Ayinon C . 257013981 . 2023-06-26 . www.mdedge.com . en. free .
  8. Neha, Kumar S, Madaan V, Sharma DV, Sharma DM, Soni SL, Sharma AK . 2022-09-15 . Oteseconazole: A Review . Journal of Biomedical and Pharmaceutical Research . en . 11 . 5 . 10.32553/jbpr.v11i5.918 . 252343000 . 2279-0594. free .
  9. Martens MG, Maximos B, Degenhardt T, Person K, Curelop S, Ghannoum M, Brand S . 107. A phase 3, randomized, double-blind study to evaluate the efficacy and safety of oteseconazole (VT-1161) oral capsules versus fluconazole and placebo in the treatment of acute vulvovaginal candidiasis episodes in subjects with recurrent vulvovaginal candidiasis (ultraViolet). . Open Forum Infectious Diseases . November 2021 . 8 . Supplement_1 . S66–S67 . US . Oxford University Press . 8644338 . 10.1093/ofid/ofab466.107 .
  10. Gupta AK, Talukder M, Venkataraman M . Review of the alternative therapies for onychomycosis and superficial fungal infections: posaconazole, fosravuconazole, voriconazole, oteseconazole . International Journal of Dermatology . 61 . 12 . 1431–1441 . December 2022 . 34882787 . 10.1111/ijd.15999 . 245013623 .