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Advances in dermatologic therapy: From clinical to cosmetic dermatology
*Corresponding author: Aravind Sivakumar, Department of Dermatology, Rio Hospital, Madurai, Tamil Nadu, India. aravinddermat@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Sivakumar A. Advances in dermatologic therapy: From clinical to cosmetic dermatology. CosmoDerma. 2026;6:10. doi: 10.25259/CSDM_193_2025
INTRODUCTION
Dermatological disorders are frequently chronic, difficult to treat, and associated with substantial morbidity in diseases such as atopic dermatitis and psoriasis. A deeper understanding of the immunological and molecular mechanisms of skin disease has led to the development of novel therapeutics that aim not only to control symptoms but also to modify disease course. This article summarizes recently approved agents and expanded indications of existing drugs, with complete details of each summarized in Table 1.
| S. No. | Drug name | Relevant clinical trial | Efficacy/Endpoints | Side effects | Available in India (November 2025) |
|---|---|---|---|---|---|
| 1 | Nemolizumab | ARCADIA 1,2 | 36% achieved IGA 0/1, and 44% achieved EASI 75 at week 16 | Conjunctivitis, injection site reaction, herpes zoster | No |
| 2 | Lebrikizumab | ADvocate 1/2 | 40% achieved IGA 0/1 and 70% with EASI 75 at week 16 | Conjunctivitis, headache, eosinophilia | No |
| 3 | Tapinarof | ADORING | 55.8% achieved EASI-75; and 45.4% with IGA 0/1 at week 8. | Folliculitis, headache, nasopharyngitis | No |
| 4 | Roflumilast | INTEGUMENT | 32% achieved IGA 0/1, and EASI-75 was seen in 43.2% cases at week 4. | Mild irritation, headache, diarrhea | No |
| 5 | Bimekizumab | BE-READY, BE-VIVID | PASI-90 was achieved in 85% cases and 84% cases with IGA 0/1 at week 16 | Oral candidiasis, infections | No |
| 6 | Upadacitinib | Measure up, Heads up | EASI-75 achieved in 72.4% by week 16 | Acne, URTI, herpes zoster, thrombosis | Yes |
| 7 | Apremilast | SPROUT | 45.4% of pediatric patients achieved PASI 75,33.1% achieved sPGA 0/1 at week 16 | GI upset, weight loss, depression | Yes |
| 8 | Spesolimab | Effisayil-1/2 | GPPGA 0/1 (clear/almost clear) at week 1 in ~54% versus 6% (placebo) | Infusion rxns, infections, DKA | No |
| 9 | Deuruxolitinib | THRIVE-AA | SALT ≤20 in 30–40% at week 24 | Acne, ↑lipids, herpes zoster | No |
| 10 | Berdazimer | B-SIMPLE 4 | Clearance in ~30% cases at week 12 | Local erythema, burning, pain | No |
| 11 | Vyjuvek | GEM-3 | 60% achieved the target wound closure at 6 months | Mild flu-like, wound reactions | No |
| 12 | Filsuvez (Oleogel-S10) | EASE | Wound closure at day 45 in 41% versus 29% placebo, plus pain reduction was clinically meaningful in 50%. | Local irritation, erythema | No |
| 13 | Prademagene Zamikercel | EB-101 trial | 80% wound closure at 6 months | Graft site pain, infections | No |
| 14 | Mirdametinib | ReNeu | ORR 42% tumor shrinkage at week 24–48 | Rash, diarrhea, edema | No |
| 15 | Mavorixafor | Phase 3 | ↑ANC and lymphocytes at day 30 in >80% cases, ↓infections at week 24 | GI upset, headache | No |
| 16 | Dupilumab | LIBERTY-CSU, LIBERTY-BP ADEPT | Marked itch reduction (UAS7 ≤6 in 50% vs. 20% placebo) at week 24.Steroid-sparing remission in 45% vs. 12% placebo at week 24 | Conjunctivitis, eosinophilia, arthritis | Yes |
| 17 | Donidalorsen | OASIS-HAE | Mean attack rate reduction by 80–90% at week 24 | Injection rxns, headache | No |
| 18 | Sebetralstat | KONFIDENT | Symptom relief in a median of 90 min in >70% attacks. | GI upset, headache. | No |
| 19 | Garadacimab | VANGUARD | Prevention of attacks in >80% patients at week 24 | Mild URTI, hypersensitivity | No |
| 20 | Remibrutinib | REMIX 1 | 49.8% achieved UAS7 score ≤7 at week 12 versus 24.8% in placebo | Petechiae, nasopharyngitis, headache, urticaria, COVID-19 | No |
| 21 | Lifileucel | C-144-01 | ORR ~30% at 12 weeks | CRS, cytopenias | No |
| 22 | Cosibelimab | Phase 3 | ORR ~47% at 12 weeks | Immune-related AEs, infusion rxns | No |
| 23 | Delgocitinib | DELTA 1/2 | PASI 75/clear-almost clear in >40–50% at week 16 versus 10% placebo | Mild burning, irritation | No |
| 24 | Axatilimab | AGAVE-201 | ORR 75% at week 24 | Cytopenia, ↑LFTs, fatigue | No |
| 25 | Sepiapterin | APHENITY | Mean Phe ↓by 60% at week 12 | Nausea, headache | No |
| 26 | Letibotulinumtoxin A | Phase 3 | Onset <1-week, durable effect up to 24 weeks; 73–80% response at week 1 | Ptosis, injection pain | No |
| 27 | Onabotulinumtoxin A | Phase 3 | Significant esthetic improvement at 1 month | Dysphagia, muscle weakness | Yes |
| 28 | Incobotulinumtoxin A | Phase 3 | Effective across the forehead, crow’s feet, and glabella at 1 month in 70% responders | Eyelid ptosis, injection pain | Yes |
| 29 | Juvederm Voluma XC | Phase 3 | >80% esthetic improvement at week 12 | Swelling, bruising | Yes |
| 30 | Sofpironium bromide | Cardigan 1/2 | AHFS improvement in >50% at week 16 versus 20% placebo | Dry mouth, local irritation | No |
| 31 | Tralokinumab | ECZTRA | Increase EASI-75, and IGA 0/1 | Conjunctivitis, ISR | No |
| 32 | Abrocitinib | JADE | Increase in EASI-75, rapid itch control | Nausea, acne, HZ reactivation | Yes |
| 33 | Lotilaner | Saturn-1/2 | Collarette and mite reduction | Stinging, irritation | No |
| 34 | Oteseconazole | UltraVIOLET | Decrease in RVVC recurrence | Headache, nausea | No |
| 35 | Ibrexafungerp | VANISH/CANDLE | Increased clinical cure | GI upset, headache | No |
| 36 | Anifrolumab | TULIP-1/2 | Increase in BICLA | URTI, zoster | No |
| 37 | Maralixibat | ICONIC | Decreased Pruritus | Diarrhea, ↑LFT | No |
| 38 | Difelikefalin | KALM-1/2 | Decreased Itch NRS | Dizziness, diarrhea | No |
| 39 | Odevixibat | PEDFIC/ASSERT | ↓Pruritus, ↓Bile acids | Diarrhea, ↑LFT | No |
| 40 | Daxibotulinum toxin | REFINE | Long duration (~24 wks) | Headache, ptosis | No |
| 41 | Deucravacitinib | POETYK 1/2 | ↑PASI-75 achieved | URTI, acne | No |
| 42 | Nivolumab + Relatlimab | RELATIVITY-047 | ↑PFS | Immune-related AEs | No |
SC: Subcutaneous, OD: Once daily, BID: Twice daily, LD: Loading dose, mAb: Monoclonal antibody, IL: Interleukin, AhR: Aryl hydrocarbon receptor, PDE-4: Phosphodiesterase-4, JAK: Janus kinase, PsA: Psoriatic arthritis, HS: Hidradenitis suppurativa, EASI: Eczema area and severity index,
IGA: Investigator’s global assessment, PASI: Psoriasis area and severity index, GPPGA: Generalized pustular psoriasis physician global assessment, SALT: Severity of alopecia tool, EB: Epidermolysis bullosa, JEB: Junctional EB, DEB: Dystrophic EB, RDEB: Recessive dystrophic EB, NF1: Neurofibromatosis type 1, WHIM: Warts, hypogammaglobulinemia, infections, myelokathexis, CSU: Chronic spontaneous urticaria, HAE: Hereditary angioedema, TIL: Tumor-infiltrating lymphocytes, cSCC: Cutaneous squamous cell carcinoma, GVHD: Graft-versus-host disease, BH4: Tetrahydrobiopterin, HA: Hyaluronic acid, AE: Adverse event, LFTs: Liver function tests, CRS: Cytokine release syndrome, AHFS: Axillary hyperhidrosis severity, PFS: Progression free survival, TNF: Tumor necrosis factor
INDICATIONS
Atopic dermatitis
Recent approvals for atopic dermatitis reflect diverse mechanisms targeting itch, inflammation, and barrier dysfunction as summarized below.
Tralokinumab is an anti-interleukin (IL)-13 monoclonal antibody approved for the treatment of moderate-to-severe atopic dermatitis in adults in 2021, and later expanded to include children aged 12 years and older in 2023.[1]
Abrocitinib is a selective Janus Kinase 1 (JAK-1) inhibitor originally approved for the treatment of moderate-to-severe atopic dermatitis in adults in 2022, and has now been expanded to include children older than 12 years of age.[2]
Nemolizumab, an IL-31 receptor antibody, is approved for use in moderate-to-severe atopic dermatitis in children over 12 years of age.[3]
Lebrikizumab, an IL-13 inhibitor, is approved for the treatment of moderate-to-severe atopic dermatitis in adolescents and adults.[4]
Tapinarof, a topical aryl hydrocarbon receptor (AhR) agonist, enhances barrier proteins and reduces inflammation, approved for children over 2 years of age.[5]
Roflumilast, a topical phosphodiesterase-4 (PDE-4) inhibitor, is approved for use in individuals aged 6 years and older.[6]
Psoriasis and psoriatic arthritis
Tapinarof, a novel topical AhR agonist, was originally approved as 1% topical cream once daily for the treatment of mild, moderate, and severe plaque psoriasis in adults.[7]
Deucravacitinib, an oral tyrosine kinase inhibitor (TYK-2) was approved for the treatment of moderate-to-severe plaque psoriasis in 2022.[8]
Bimekizumab (dual IL-17A/F blockade) shows superior long-term efficacy compared with older biologics in moderate-to-severe plaque psoriasis and was approved in 2023. It is now also approved in 2024 for the treatment of active psoriatic arthritis and hidradenitis suppurativa.[9,10]
Upadacitinib, a selective oral JAK-1 inhibitor, is now approved in pediatric psoriatic arthritis refractory to tumor necrosis factor blockers[11]
Apremilast, a PDE-4 inhibitor, has been granted extended approval for pediatric psoriasis for over 6 years.[12]
Spesolimab, targeting IL-36, originally approved in generalized pustular psoriasis for adults in 2022, now has an expanded indication including children ≥12 years.[13,14]
Alopecia areata
Ritlecitinib: It is an oral selective JAK-3 inhibitor approved for the treatment of severe alopecia areata in adults and children 12 years and older.[15]
Deuruxolitinib, an oral JAK-1/2 inhibitor, became the third approved JAK agent for severe alopecia areata, achieving meaningful hair regrowth with an acceptable safety profile.[16]
Infectious dermatoses
Berdazimer, a nitric oxide-releasing topical, is the first patient-applied treatment approved for molluscum contagiosum in children older than one year of age, offering a convenient and effective alternative to destructive therapies[17]
Lotilaner: It is a topical solution approved for the treatment of demodex blepharitis in adults.[18]
Oteseconazole is an oral azole antifungal approved for reducing the incidence of recurrent vulvovaginal candidiasis in women not of reproductive potential.[19]
Ibrexafungerp is a novel triterpenoid non-azole fungicidal oral agent first approved in 2021 for the treatment of vulvovaginal candidiasis in adults and post-menarchal females older than 12 years. In 2022, it was approved for reducing the incidence of recurrent vulvovaginal candidiasis (VVC).[20]
Genodermatoses
The following agents have been recently approved for treating epidermolysis bullosa (EB):
Vyjuvek (Beremagene -geperpavec), a topical herpes simplex virus-1 (HSV-1)-based gene therapy, delivers collagen 7 (COL7) protein and promotes wound healing, approved for dystrophic EB in children 6 months and older.[21]
Filsuvez (Oleogel S10), a birch bark-derived gel consisting of birch bark triterpenes such as betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid, reduces EB disease activity scores and is approved for junctional EB and dystrophic EB in children over 6 months of age.[22]
Prademagene zamikercel is the first autologous cell-based gene therapy for recessive dystrophic EB (RDEB), demonstrating sustained wound closure in adults and children with RDEB.[23]
Other recently approved drugs in genodermatoses include:
Mirdametinib (a mitogen activated protein kinase kinase [MEK] inhibitor) is approved for inoperable plexiform neurofibroma in neurofibromatosis type 1 (NF-1) among adults and children older than 2 years of age.[24]
Mavorixafor, an oral C-X-C motif chemokine receptor 4 (CXCR-4) antagonist, improves immune function and reduces infections in warts, hypogammaglobulinemia, infections and myelokathexis syndrome, approved in adults and children older than 12 years.[25]
Urticaria and angioedema
Dupilumab is now approved for chronic spontaneous urticaria refractory to antihistamines in children over 12 years of age and for the treatment of adults with bullous pemphigoid.[22,26]
For hereditary angioedema, the following drugs have recently been approved: donidalorsen (RNA therapy), which prevents attacks; sebetralstat, which provides rapid oral relief during acute flares; and garadacimab, which blocks factor XII to reduce recurrence.[27]
Remibrutinib, a novel oral Bruton TYK-2, is the newest drug approved for chronic spontaneous urticaria in adults.[28]
Cutaneous oncology
Nivolumab plus Relatilimab (Opdualag™) is a combination immunotherapy targeting PD-1 stands for Programmed cell Death protein 1 (PD-1)/LAG-3 is Lymphocyte Activation Gene-3 (LAG-3) receptor protein approved in 2022 for the treatment of metastatic or unresectable melanoma in adults and children more than 12 years of age.[29]
Lifileucel, the first tumor-infiltrating lymphocyte therapy in solid malignancy, was approved for metastatic or unresectable melanoma previously treated with PD-1 or B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitors.[22]
Cosibelimab, a PD-L1 antibody, is approved for locally advanced or metastatic cutaneous squamous cell carcinoma not eligible for curative surgery or radiation.[22]
Inflammatory dermatoses
Delgocitinib, a topical pan-JAK inhibitor, is now approved for moderate-to-severe chronic hand eczema unresponsive to steroids.[22]
Axatilimab, targeting colony stimulating factor 1 receptor (CSF-1) receptor, is approved for treating refractory chronic graft versus host disease in adults and children who failed at least two systemic agents.[22]
Anifrolumab is a type 1 interferon receptor antagonist approved in 2021 for the treatment of moderate-to-severe systemic lupus erythematosus in adults on standard therapy.[30]
Metabolic and pruritic disorders
Sepiapterin, a precursor of tetrahydrobiopterin, is approved for phenylketonuria treatment in adults and children older than 1 year. It showed superior bioavailability compared to earlier cofactors.[22]
Maralixibat is an Ileal bile acid transporter (IBAT) approved for use in cholestatic pruritus associated with Alagille syndrome in children aged 1 year and older (2021) and in progressive familial intrahepatic cholestasis in children aged 1 year and older (2024).[31]
Difelikefalin is a synthetic kappa opioid receptor agonist approved for use in 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.[32]
Odevixibat is an IBAT inhibitor approved for use in children aged 3 months and older with progressive familial intrahepatic cholestasis (2021) and in 2023 in children older than 1 year with cholestatic pruritus associated with Alagille syndrome.[33]
Cosmetic dermatology
Esthetic indications continue to expand:
Daxibotulinum toxin A-lanm is approved for the temporary treatment of moderate-to-severe glabellar lines in adults.[34]
Letibotulinumtoxin A is approved for glabellar lines.[22]
Onabotulinumtoxin A is the only neurotoxin approved for treating platysmal bands.[22]
Incobotulinumtoxin A is now approved for treating all upper facial lines.[22]
Juvederm Volume XC is approved for correcting temporal hollowing.[22]
Sofpironium bromide, a topical anticholinergic gel, is approved for primary axillary hyperhidrosis in adults and children older than 9 years of age.[35]
CONCLUSION
Dermatology is rapidly advancing with biologics, small molecules, gene and cell-based therapies, expanding treatment options across inflammatory, genetic, oncologic, infectious, and cosmetic skin conditions, making it essential for residents and practitioners to stay updated with the newer treatment options.
Ethical approval:
Institutional Review Board approval is not required.
Declaration of patient consent:
Patient’s consent not required as there are no patients in this study.
Conflicts of interest:
There are no conflict of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript, and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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