Berdazimer sodium

Last updated

Berdazimer sodium
Berdazimer sodium.svg
Clinical data
Trade names Zelsuvmi
Other namesSB206
AHFS/Drugs.com Monograph
MedlinePlus a624007
License data
Routes of
administration
Topical
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
Formula Indeterminate [1]
Molar mass Indeterminate [1]

Berdazimer sodium, sold under the brand name Zelsuvmi, is a medication used for the treatment for molluscum contagiosum. [1] Berdazimer sodium is a nitric oxide releasing agent. [1] It is a polymer formed from sodium 1-hydroxy-3-methyl-3-(3-(trimethoxysilyl)propyl)-1-triazene-2-oxide and tetraethyl silicate. [2]

Contents

The most common side effects occurred at the drug application site including pain, rash, itch, eczema, swelling, erosion, discoloration, blister, irritation, and infection. [3] Other common side effects included fever, vomiting, and upper respiratory infections (common cold). [3]

Berdazimer sodium was approved for medical use in the United States in January 2024. [4] [5] [6]

Medical uses

Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum. [1]

Pharmacology

Mechanism of action

Berdazimer sodium is a nitric oxide releasing agent. [1] The mechanism of action for the treatment of molluscum contagiosum is unknown. [1]

History

The US Food and Drug Administration (FDA) approved berdazimer sodium based on evidence from three clinical trials (NI-MC301, NI-MC302, and NI-MC304) of 1,598 participants with molluscum contagiosum. [3] The trials were conducted at 121 sites in the United States. [3] Among the 1,598 enrolled participants, all of them were evaluated for efficacy and 1,596 were evaluated for safety. [3] In all three trials, participants with molluscum contagiosum were randomized to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks. [3] Efficacy was assessed as the proportion of participants achieving complete clearance at week twelve. [3] Complete clearance was defined as the subject having a total of molluscum contagiosum lesion count of zero at assessment. [3] Trial 1 enrolled 891 participants, trial 2 enrolled 355 participants, and trial 3 enrolled 352 participants. [1] Participants were randomized 1:1 in trial 1, and 2:1 in trials 2 and 3 to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks. [1]

Society and culture

Berdazimer sodium was approved for medical use in the United States in January 2024. [3] [5]

Names

Berdazimer sodium is the international nonproprietary name. [7]

Berdazimer sodium is sold under the brand name Zelsuvmi. [1]

Related Research Articles

<span class="mw-page-title-main">Molluscum contagiosum</span> Viral infection of the skin

Molluscum contagiosum (MC), sometimes called water warts, is a viral infection of the skin that results in small raised pink lesions with a dimple in the center. They may become itchy or sore, and occur singularly or in groups. Any area of the skin may be affected, with abdomen, legs, arms, neck, genital area, and face being the most common. Onset of the lesions is around seven weeks after infection. They usually go away within a year without scarring.

<span class="mw-page-title-main">Adapalene</span> Third-generation topical retinoid

Adapalene is a third-generation topical retinoid primarily used in the treatment of mild-moderate acne, and is also used off-label to treat keratosis pilaris as well as other skin conditions. Studies have found adapalene is as effective as other retinoids, while causing less irritation. It also has several advantages over other retinoids. The adapalene molecule is more stable compared to tretinoin and tazarotene, which leads to less concern for photodegradation. It is also chemically more stable compared to the other two retinoids, allowing it to be used in combination with benzoyl peroxide. Due to its effects on keratinocyte proliferation and differentiation, adapalene is superior to tretinoin for the treatment of comedonal acne and is often used as a first-line agent. The Swiss company Galderma sells adapalene under the brand name Differin.

<span class="mw-page-title-main">Desonide</span> Chemical compound

Desonide (INN) is a low-potency topical corticosteroid anti-inflammatory that has been available since the 1970s. It is primarily used to treat atopic dermatitis (eczema), seborrheic dermatitis, contact dermatitis and psoriasis in both adults and children. It has a fairly good safety profile and is available as a cream, ointment, lotion, and as a foam under the tradename Verdeso Foam. Other trade names for creams, lotions, and ointments include Tridesilon, DesOwen, Desonate. It is a group VI corticosteroid under US classification, the second least potent group.

<span class="mw-page-title-main">Imiquimod</span> Chemical compound

Imiquimod, sold under the brand name Aldara among others, is a medication that acts as an immune response modifier that is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis.

<span class="mw-page-title-main">Cysteamine</span> Chemical compound

Cysteamine is an organosulfur compound with the formula HSCH2CH2NH2. A white, water-soluble solid, it contains both an amine and a thiol functional groups. It is often used as salts of the ammonium derivative [HSCH2CH2NH3]+ including the hydrochloride, phosphocysteamine, and the bitartrate.The intermediate pantetheine is broken down into cysteamine and pantothenic acid.

Naproxcinod (nitronaproxen) is a nonsteroidal anti-inflammatory drug (NSAID) developed by the French pharmaceutical company NicOx. It is a derivative of naproxen with a nitroxybutyl ester to allow it to also act as a nitric oxide (NO) donor. This second mechanism of action makes naproxcinod the first in a new class of drugs, the cyclooxygenase inhibiting nitric oxide donators (CINODs), that are hoped to produce similar analgesic efficacy to traditional NSAIDs, but with less gastrointestinal and cardiovascular side effects.

<span class="mw-page-title-main">Dupilumab</span> Drug used to treat allergic diseases

Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. It is also used for the treatment of eosinophilic esophagitis and prurigo nodularis.

<span class="mw-page-title-main">Abacavir/dolutegravir/lamivudine</span> Combination medication for HIV

Abacavir/dolutegravir/lamivudine, sold under the brand name Triumeq among others, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It is a combination of three medications with different and complementary mechanisms of action: abacavir, dolutegravir and lamivudine.

<span class="mw-page-title-main">Calcipotriol/betamethasone dipropionate</span> Combination drug

Calcipotriol/betamethasone dipropionate, sold under the brand name Taclonex among others, is a fixed-dose combination medication of the synthetic vitamin D3 analog calcipotriol (also known as calcipotriene) and the synthetic corticosteroid betamethasone dipropionate for the treatment of plaque psoriasis. It is used in the form of ointment, topical suspension, gel, aerosol, and foam.

<span class="mw-page-title-main">Clascoterone</span> Chemical compound

Clascoterone, sold under the brand name Winlevi, is an antiandrogen medication which is used topically in the treatment of acne. It is also under development in a higher concentration for the treatment of androgen-dependent scalp hair loss, under the brand name Breezula. The medication is used as a cream by application to the skin, for instance the face and scalp.

<span class="mw-page-title-main">Upadacitinib</span> Biopharmaceutical drug

Upadacitinib, sold under the brand name Rinvoq, is a medication used for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and axial spondyloarthritis. Upadacitinib is a Janus kinase (JAK) inhibitor that works by blocking the action of enzymes called Janus kinases. These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.

<span class="mw-page-title-main">Zanubrutinib</span> Chemical compound

Zanubrutinib, sold under the brand name Brukinsa, is an anticancer medication used for the treatment of mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL). Zanubrutinib is classified as a Bruton's tyrosine kinase (BTK) inhibitor. It is given by mouth.

Givosiran, sold under the brand name Givlaari, is a medication used for the treatment of adults with acute hepatic porphyria. Givosiran is a small interfering RNA (siRNA) directed towards delta-aminolevulinate synthase 1 (ALAS1), an important enzyme in the production of heme.

<span class="mw-page-title-main">Abrocitinib</span> Chemical compound

Abrocitinib, sold under the brand name Cibinqo, is a medication used for the treatment of atopic dermatitis (eczema). It is a Janus kinase inhibitor and it was developed by Pfizer. It is taken by mouth.

Atoltivimab/maftivimab/odesivimab, sold under the brand name Inmazeb, is a fixed-dose combination of three monoclonal antibodies for the treatment of Zaire ebolavirus. It contains atoltivimab, maftivimab, and odesivimab-ebgn and was developed by Regeneron Pharmaceuticals.

<span class="mw-page-title-main">Cabotegravir/rilpivirine</span> Co-packaged antiretroviral medication

Cabotegravir/rilpivirine, sold under the brand name Cabenuva, is a co-packaged antiretroviral medication for the treatment of HIV/AIDS. It contains cabotegravir and rilpivirine in a package with two separate injection vials.

<span class="mw-page-title-main">Lenacapavir</span> Antiretroviral medication

Lenacapavir, sold under the brand name Sunlenca, is an antiretroviral medication used to treat HIV/AIDS. It is taken by mouth or by subcutaneous injection.

<span class="mw-page-title-main">Sofpironium bromide</span> Chemical compound

Sofpironium bromide, sold under the brand name Ecclock among others, is a medication used to treat hyperhidrosis. Sofpironium bromide is an anticholinergic agent that is applied to the skin.

Bexagliflozin, sold under the brand name Brenzavvy, is an antidiabetic medication used to improve glycemic control in adults with type 2 diabetes. It is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that is taken by mouth.

<span class="mw-page-title-main">Birch triterpenes</span> Medication

Birch triterpenes, sold under the brand name Filsuvez, is an extract of birch bark used as a topical medication for the treatment of epidermolysis bullosa. The active ingredients are triterpenes extracted from the outer bark of silver birch and downy birch.

References

  1. 1 2 3 4 5 6 7 8 9 10 11 "Zelsuvmi (berdazimer) topical gel" (PDF). Archived (PDF) from the original on 19 January 2024. Retrieved 9 January 2024.
  2. "Berdazimer sodium". GSRS. Archived from the original on 8 January 2024. Retrieved 8 January 2024.
  3. 1 2 3 4 5 6 7 8 9 "Drug Trials Snapshots: Zelsuvmi". U.S. Food and Drug Administration (FDA). 5 January 2024. Archived from the original on 29 August 2024. Retrieved 2 September 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  4. "Drug Approval Package: Zelsuvmi". U.S. Food and Drug Administration (FDA). 2 February 2024. Archived from the original on 11 March 2024. Retrieved 11 March 2024.
  5. 1 2 "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
  6. "U.S. Food and Drug Administration Approves Zelsuvmi as a First-in-Class Medication for the Treatment of Molluscum Contagiosum". Ligand Pharmaceuticals. 5 January 2024. Archived from the original on 8 January 2024. Retrieved 8 January 2024 via Business Wire.
  7. World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl: 10665/330941 .

Further reading