Filsuvez (AP101) / Chiesi - LARVOL DELTA

Update on Approved Therapies for Dystrophic and Junctional Epidermolysis Bullosa. (PubMed, Pediatr Dermatol) - "Since 2022, three therapies - birch triterpenes gel (Filsuvez), beremagene geperpavec-svdt (B-VEC, Vyjuvek), and prademagene zamikeracel (pz-cel, Zevaskyn) - have received regulatory approval, representing the first specific interventions for epidermolysis bullosa. Herein, we provide an overview on their mechanisms of action, efficacy, safety, and clinical implications."

Journal • Review • Dermatology • Gene Therapies

FILS-EBS: Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Stanford University

New P2 trial

Chiesi Global Rare Diseases Announces Health Canada Grants Priority Review for FILSUVEZ (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa (The Manila Times) - "The submission is supported by data from the pivotal Phase 3 trial, EASE..."

Canada filing • Priority review • Dermatology

A randomized, phase II, double-blinded study of the efficacy of oleogel-S10 (AP101) gel for the treatment of grade 2/3 radiation dermatitis in breast cancer patients. (ASCO 2026) - P2 | "Patients were randomized 1:1 to Oleogel-S10 or placebo and instructed to apply standard-of-care triamcinolone 0.1% cream daily with study gel nightly for three weeks. Although Oleogel-S10 did not improve the primary endpoint of wound surface area as calculated by a novel 3D imaging tool compared with standard-of-care triamcinolone, treatment was associated with a trend toward improvement in skin pain and hyperpigmentation. These findings may represent early signals of therapeutic activity in ARD, particularly for patient-centered outcomes. Interpretation is limited by early study closure related to COVID-19–associated recruitment challenges and small sample size."

Clinical • P2 data • Breast Cancer • Dermatitis • Dermatology • Immunology • Infectious Disease • Oncology • Pruritus • Skin Cancer • Solid Tumor

Long-Term Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa. (PubMed, Pediatr Dermatol) - P3 | "These analyses of pediatric patients demonstrated accelerated wound healing, reduced frequency of dressing changes, and sustained reduction in wound burden up to 27 months. Long-term safety was consistent with the overall EASE population."

Journal • Pediatrics

Epidermal regeneration in recessive dystrophic epidermolysis bullosa after treatment with birch bark extract: evidence from close clinical and line-field confocal optical coherence tomography monitoring (AAD 2026) - "Conclusion Although limited by sample size, this real-world study confirmed rapid and consistent efficacy of birch bark extract. It also highlighted the utility of LC-OCT as a valuable tool for real-time, non-invasive monitoring of wound healing dynamics in RDEB."

Clinical

Understanding the efficacy and tolerability of topical therapies for epidermolysis bullosa. (PubMed, Expert Rev Clin Pharmacol) - "This review examines the clinical efficacy and tolerability of topical therapies for EB, with a particular focus on approved treatments such as beremagene geperpavec (B-VEC) and Oleogel-S10, as well as emerging agents like allantoin, diacerein, sirolimus, gentamicin, gentian violet and calcipotriol...The continued use of standardized outcome measures will affect the future progress of studies, as well as using real-world data. Whilst a definitive cure is unlikely for EB, evolving topical strategies have strong potential in providing control of the disease's symptoms and ultimately can improve long-term outcomes."

Journal • Review • Dermatology • Pain

SG12 A rare case of perianal granular cell tumour in a patient with localized recessive dystrophic epidermolysis bullosa. (PubMed, Br J Dermatol) - "The wound site was left open to promote healing; however, this was complicated by concomitant RDEB resulting in persisting well-demarcated ulceration unresponsive to topical Oleogel-S10, mupirocin 2% and Trimovate®. Botulinum toxin injections, topical glyceryl trinitrate and diltiazem are now being considered as the next step for this patient, with the aim of encouraging skin healing by relaxing the anal sphincter muscle...Additionally, this case presents the importance of tailored examinations under anaesthesia to facilitate perianal diagnoses in patients with EB, where skin fragility and pain limit the feasibility of routine examination methods. This case joins the existing literature that reports the challenges of wound healing in EB postoperatively, but importantly suggests that future management of other, nonsurgical perianal wounds in EB could also utilize similar techniques involving therapeutic anal sphincter muscle relaxation."

Journal • Anesthesia • Oncology • Pain • CD68

Epidermal regeneration in recessive dystrophic epidermolysis bullosa following treatment with birch bark extract: insights from line field confocal optical coherence tomography imaging (EADV 2025) - "LC-OCT imaging confirmed early full epidermal regeneration, including a fully developed stratum corneum, in patients with RDEB following the topical application of birch bark extract as soon as after a few days. In addition, it allowed a timely non-invasive temporal evaluation of changes during progressive wound re-epithelialization. This in vivo model demonstrated that LC-OCT enables non-invasive, real-time tracking of wound healing dynamics in RDEB, supporting its potential for broader application in non-invasive dermatological research."

Dermatology • Pruritus

Methodological Concerns in the EASE Study of Oleogel-S10 for Epidermolysis Bullosa: reply from authors. (PubMed, Br J Dermatol) - No abstract available

Journal

Methodological Concerns in the EASE Study of Oleogel-S10 for Epidermolysis Bullosa. (PubMed, Br J Dermatol) - No abstract available

Journal

Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa-Impact of Oleogel-S10. (PubMed, J Dermatol) - P3 | "Estimated dressing costs reduced by 59%, from $63.4 k to $25.9 k per patient over 27 months. Oleogel-S10 significantly reduced dressing frequency and time burden, with potential to ease the intensive demands of EB wound care."

Clinical • Journal • Genetic Disorders • Mood Disorders • Pain

Real-world case series: Birch triterpenes gel efficacy in 2 patients with junctional epidermolysis bullosa. (PubMed, JAAD Case Rep) - No abstract available

Journal • Real-world evidence

REVIVE: A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P3 | N=6 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Genetic Disorders • Rheumatology

Mediterranean Basin Erica Species: Traditional Uses, Phytochemistry and Pharmacological Properties. (PubMed, Molecules) - "Filsuvez®, comprising pentacyclic triterpenes from birch bark, has clinical approval for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa. The undoubted reservoir of pentacyclic triterpenes and flavonoid glycosides in Mediterranean Erica species warrants further comprehensive mechanistic studies, toxicological evaluations and clinical validation."

Journal • Review • Gastrointestinal Disorder • Pain

Towards Extracellular Vesicles in the Treatment of Epidermolysis Bullosa. (PubMed, Bioengineering (Basel)) - "Current treatments focus on symptomatic relief through wound care and pain management, with recent FDA approvals of Vyjuvek and Filsuvez providing new but limited therapeutic options...However, challenges remain, including standardization of EV production, scalability, and ensuring consistent therapeutic potency. Despite these hurdles, EV-based therapies represent a transformative step toward addressing the complex pathology of EB, with the potential to improve wound healing, reduce fibrosis, and enhance patient quality of life."

Journal • Review • Dermatology • Fibrosis • Graft versus Host Disease • Immunology • Oncology • Pain

REVIVE: A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P3 | N=6 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P3 trial • Dermatology • Genetic Disorders • Rheumatology

FOSteR: A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez (clinicaltrials.gov) - P=N/A | N=580 | Recruiting | Sponsor: Amryt Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Oncology • Skin Cancer

Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the Phase III EASE Study. (PubMed, Br J Dermatol) - "These data support an encouraging long-term safety profile of Oleogel-S10, and a sustained reduction in wound burden over at least 24 months of Oleogel-S10 treatment."

Journal • P3 data • Genetic Disorders • Infectious Disease • Pain

From Plant to Patient: A Historical Perspective and Review of Selected Medicinal Plants in Dermatology. (PubMed, JID Innov) - "This review covers various plant-derived therapeutics (polyphenon E [sincatechins], psoralen, salicylic acid, anthralin, podophyllotoxin, and Filsuvez [birch triterpenes, oleogel-S10]) that have demonstrated scientific evidence of clinical efficacy for dermatologic disorders. The discovery, composition, history of use, and current uses in dermatology are summarized for each botanical ingredient."

Journal • Review • Acne Vulgaris • Dermatology • Immunology • Psoriasis • Vitiligo

Effect of Triterpene Extract on Skin Cohesion in Epidermolysis Bullosa (EADV 2024) - "Collectively, our data suggest potential context-dependent skin stabilizing properties of TE in JEB and DEB. TE in JEB evokes, basal localization of cell-matrix adhesion complexes adhesion strength, which may account for the improved epidermal to dermal cohesion observed in TE-treated JEB HSEs. This finding, coupled with other pre- clinical studies, further supports the clinically demonstrated wound healing properties of Oleogel-S10 specifically in JEB and DEB."

KRT14 • LORICRIN

Effect of Triterpene Extract on Skin Cohesion in Epidermolysis Bullosa (EADV 2024) - "Collectively, our data suggest potential context-dependent skin stabilizing properties of TE in JEB and DEB. TE in JEB evokes, basal localization of cell-matrix adhesion complexes adhesion strength, which may account for the improved epidermal to dermal cohesion observed in TE-treated JEB HSEs. This finding, coupled with other pre- clinical studies, further supports the clinically demonstrated wound healing properties of Oleogel-S10 specifically in JEB and DEB."

Dermatology • KRT14 • LORICRIN

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Completed | N=50 ➔ 18 | Trial completion date: Dec 2026 ➔ Aug 2024 | Trial primary completion date: Dec 2026 ➔ Aug 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor

FOSteR: A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez (clinicaltrials.gov) - P=N/A | N=580 | Not yet recruiting | Sponsor: Amryt Pharma

New trial • Genetic Disorders • Oncology • Skin Cancer

Oleogel-S10 reduces dressing changes burden and associated costs in patients with epidermolysis bullosa (SID 2024) - No abstract available

Clinical