Evidence-based
drug selection
for dermatology

Topical photosensitizer (ALA prodrug). FDA approved September 14, 2026 (sNDA) for superficial basal cell carcinoma (sBCC) in adults (≥18y) in combination with photodynamic therapy via BF-RhodoLED® lamp. First and only topical PDT drug FDA-approved to treat a skin cancer. Ameluz was previously marketed for actinic keratosis (AK). Mechanism: ALA is converted intracellularly to protoporphyrin IX; red-light activation generates reactive oxygen species that selectively destroy tumor cells. HCP-administered only. Key warnings: photosensitivity (avoid sunlight/bright indoor light to treated areas after application until illumination is complete); use only with approved BF-RhodoLED® or RhodoLED® XL lamp. No BBW. Phase 3 trial NCT03573401 supported approval. Commercial rollout for sBCC indication planned late Q4 2026 – Q1 2027.

Genetically modified oncolytic viral therapy (HSV-1-based; encodes GALV-GP-R− fusogenic glycoprotein + GM-CSF; ICP34.5 and ICP47 deleted). FDA granted accelerated approval August 6, 2026 for unresectable advanced cutaneous melanoma in combination with nivolumab in adults (≥18y) who experienced disease progression on a PD-1–blocking antibody-based regimen. Administered by intralesional injection. First oncolytic viral therapy approved in the US since T-VEC (Imlygic) in 2015. Breakthrough Therapy and Priority Review designations. Efficacy: ORR 24.2% (95% CI 15.8–34.3); median DOR 14.1 months (IGNYTE trial, n=91 efficacy-evaluable). Confirmatory trial IGNYTE-3 ongoing. No BBW.

IL-23 inhibitor. Approved June 26, 2026 for moderate-to-severe plaque psoriasis and active psoriatic arthritis in patients ≥6y. Weight-based dosing: 55mg SC (<40kg) or 150mg SC (≥40kg) at wk0, wk4, then q12wks. New 55mg prefilled syringe simultaneously approved. PsA approval extrapolated from psoriasis data (OptIMMize-1/2 trials). Previously approved for adults only.

Topical PDE4 inhibitor. Approved June 29, 2026 for plaque psoriasis (including intertriginous areas) in patients ≥2y. Once daily; no duration restriction. First topical PDE4 inhibitor approved for psoriasis in patients under 6. Contraindicated in moderate-to-severe hepatic impairment (Child-Pugh B or C). Supported by MUSE pediatric PK/safety study.

First oral IL-23R antagonist (cyclic peptide). Approved March 18, 2026 for plaque psoriasis ≥12y and ≥40kg. 200mg once daily oral. Superior to deucravacitinib in head-to-head Phase 3 (PASI 90: 55% vs 30%). No BBW. ICONIC-ASCEND (vs. ustekinumab) ongoing.

Next-gen TYK2 inhibitor. Phase 3 (LATITUDE-PsO-3001/3002) positive. NDA filing planned 2026. Phase 3 for PsA ongoing.

Next-gen TYK2 inhibitor. Phase 3 (ONWARD1/2) positive — PASI 75 ~74%. NDA filing H2 2026. ONWARD3 extension ongoing.

IL-13 inhibitor. FDA approved June 9, 2026 a new every-8-week (Q8W) maintenance dosing regimen for atopic dermatitis. After induction (500mg at wks 0 and 2, then 250mg Q2W through wk16), patients may now maintain on 250mg Q8W OR Q4W — as few as 6 injections per year. Only biologic for AD with an approved Q8W maintenance regimen. Supported by ADjoin Phase 3 LTE and exposure-response modeling.

Anti-OX40L biologic. Phase 3 (COAST 1/2, SHORE) positive. Global regulatory submissions planned H2 2026. Q4W or Q12W dosing.

Oral TYK2 inhibitor for AD. Phase 2 positive (JAMA Derm 2026). Phase 3 (579 patients) underway.

Anti-OX40 biologic. Phase 3 met endpoints but discontinued March 2026 due to emerging safety concerns.

Oral JAK1 inhibitor. Phase 3 (STOP-HS1/2) positive — HiSCR50 ~60–71%. NDA filing late 2025/early 2026. Also Phase 3 for vitiligo and PN.

IL-17A/F nanobody. Phase 3 (VELA-1/2) — VELA-1 met endpoint; VELA-2 narrowly missed. BLA on track for submission end of September 2026 (not yet formally confirmed filed as of September 13, 2026). BLA includes adults and adolescents ≥12y. Priority Review designation to be requested. Positive final pre-BLA meeting with FDA confirmed. 52-week VELA extension data: HiSCR75 67.2%. FDA acceptance and Priority Review decision expected within 60 days of filing; potential US launch H2 2027 under standard review.

Anti-CD20 monoclonal antibody biosimilar referencing Rituxan (rituximab). FDA approved 2026-08-01 for moderate-to-severe pemphigus vulgaris in adults (≥18y). US commercial launch date not yet announced as of 2026-08-23. Not designated interchangeable at time of approval. BBW: fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy (PML). Note: Truxima (rituximab-abbs) received interchangeability designation 2026-07-01 — flagged for separate review.

Full Phase 3 Viti-Up-1 & Viti-Up-2 results published The Lancet (August 15, 2026). Co-primary endpoints T-VASI50 and F-VASI75 both met at Week 48. sNDA/sMAA submitted to FDA & EMA on February 3, 2026; review ongoing. No PDUFA date confirmed. Potential first systemic therapy approved for vitiligo.

JAK3/TEC inhibitor. Phase 3 for vitiligo ongoing (est. completion 2026). Already approved for alopecia areata (Litfulo).

Oral TYK2/JAK1 inhibitor. FDA approved August 27, 2026 as the first oral treatment for dermatomyositis in adults (≥18y). 30 mg once daily. Based on Phase 3 VALOR trial (N=241). BBW: serious infections, malignancy, MACE, thrombosis. Not recommended in combination with other JAK inhibitors, TYK2 inhibitors, or biologic DMARDs.