Clinical Trials
228
4 active
Approvals
41
Total approvals
Agencies
4
Regulatory bodies
Founded
N/A
Active, not recruiting
3
1.3%
Completed
203
89.0%
Enrolling By Invitation
1
0.4%
Recruiting
4
1.8%
Terminated
15
6.6%
Withdrawn
2
0.9%
- The FDA has accepted for filing and granted Priority Review to LEO Pharma's NDA for dersimelagon in erythropoietic protoporphyria and X-linked protoporphyria, with a PDUFA date by end of February 2027. - LEO Pharma has closed its acquisition of worldwide dersimelagon rights from Tanabe Pharma for up to USD 435 million in upfront and near-term milestone payments plus tiered royalties. - Dersimelagon is an investigational once-daily oral small-molecule MC1R agonist that could become the first oral treatment for EPP and XLP if approved. - The Phase 3 INSPIRE study showed statistically significant and clinically meaningful results across primary and secondary endpoints, including prolonged daily sunlight exposure time to first prodromal symptoms.
- LEO Pharma has agreed to acquire worldwide rights to the investigational drug dersimelagon from Tanabe Pharma for up to $435 million in up-front and near-term milestone payments. - Dersimelagon is an oral, once-daily melanocortin-1 receptor (MC1R) agonist being developed for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), rare genetic disorders causing extreme sunlight sensitivity. - In Phase 3 INSPIRE trials, treated patients tolerated sunlight an average of 23 minutes longer before prodromal symptoms compared to placebo, and the FDA could approve the drug as early as 2027. - If approved, dersimelagon would become the first oral treatment for EPP and XLP, offering an alternative to the implant-based therapy Scenesse.
- LEO Pharma has entered into a definitive agreement to acquire Replay for $50 million upfront, adding a next-generation herpes simplex virus (HSV) gene therapy platform to its dermatology pipeline. - The acquisition targets rare genetic skin diseases, with Replay's lead program focusing on dystrophic epidermolysis bullosa (DEB), a devastating condition that causes fragile, easily blistered skin. - Replay's HSV gene therapy platform leverages the virus's natural tropism for skin cells and ability to deliver large genes through a topical gel formulation applied directly to the skin. - The deal strengthens LEO Pharma's position in rare dermatology and gene therapy innovation, combining six decades of dermatology expertise with Replay's specialized viral vector technology.
- China's National Medical Products Administration (NMPA) has approved LEO Pharma's Enstilar (calcipotriene/betamethasone dipropionate) foam for treating adult patients with plaque psoriasis, expanding access for an estimated 6.5 million Chinese adults living with the condition. - A phase 3 trial with 604 Chinese patients demonstrated Enstilar foam's superiority over Daivobet ointment, achieving primary and secondary endpoints with rapid onset of action and clinically meaningful improvements in quality of life within 2-4 weeks. - The approval strengthens LEO Pharma's position in the world's largest psoriasis market by patient numbers and marks a significant milestone for the company's expansion strategy in China's growing dermatology treatment sector.
- LEO Pharma presented 17 scientific abstracts at the 2026 American Academy of Dermatology Annual Meeting, showcasing real-world evidence for its dermatology treatments. - The presentations covered three key therapeutic areas: atopic dermatitis with ADBRY (tralokinumab), generalized pustular psoriasis with SPEVIGO (spesolimab), and chronic hand eczema with ANZUPGO (delgocitinib). - Data from the international TRACE study demonstrated sustained effectiveness of tralokinumab over 12 months in patients with moderate-to-severe atopic dermatitis. - Long-term efficacy data for spesolimab showed prevention of flares in generalized pustular psoriasis patients over three years of treatment.
- Over 100 pharmaceutical companies are actively developing more than 100 pipeline drugs for eczema treatment, representing a significant expansion in therapeutic options for this chronic inflammatory skin condition. - Sanofi's Amlitelimab achieved all primary and key secondary endpoints in the Phase III COAST 1 study, demonstrating statistically significant skin clearance in patients with moderate-to-severe atopic dermatitis at Week 24. - The pipeline features diverse mechanisms of action including OX40 ligand inhibitors, interleukin receptor antagonists, and STAT6 transcription factor degraders, with approximately 10+ drugs in late-stage development. - Recent clinical milestones include positive Phase I results for Concerto Biosciences' ENS-002 topical biotherapeutic and FDA clearance for Sitryx Therapeutics' SYX-5219 Phase Ib trial.
- LEO Pharma's investigational monoclonal antibody temtokibart met its primary endpoint in a Phase 2b trial, demonstrating significant improvements in EASI scores for three highest doses in moderate-to-severe atopic dermatitis patients. - The drug showed rapid onset of action with significant improvements observed as early as Week 1 for some doses, and sustained efficacy maintained up to Week 32 despite treatment cessation at Week 14. - Biomarker analysis revealed 97% improvement in immune gene expression by Week 16, with strong correlations between clinical improvements and dampening of key immune pathways. - Temtokibart demonstrated a favorable safety profile with no dose-dependent adverse events, low conjunctivitis incidence, and no herpes signal in the 262-patient study.
- Orbital Therapeutics has appointed Adam Raff, M.D., Ph.D., as Senior Vice President of Clinical Development to oversee clinical and regulatory strategy for the company's RNA medicine portfolio. - Dr. Raff will lead the advancement of OTX-201, a potential best-in-class program targeting B cell-driven autoimmune diseases, with clinical development expected to begin in the first half of 2026. - The appointment comes as Orbital progresses OTX-201 through IND-enabling studies following encouraging preclinical data, positioning the company to translate its innovative RNA platform into clinical applications. - Dr. Raff brings over a decade of drug development experience, including leadership roles at Montai Therapeutics, EQRx, and LEO Pharma, with extensive expertise in immunology and inflammatory disorders.
- Targeted protein degradation (TPD) has evolved from niche science to mainstream drug development, with over 40 PROTAC candidates in clinical testing and the first potential market approval expected for Arvinas/Pfizer's ARV-471 by June 2026. - Major pharmaceutical companies have committed over $10 billion in partnerships since 2024, with deals including AbbVie's $1.64 billion agreement with Neomorph and LEO Pharma's $1.7 billion alliance with Gilead Sciences. - The Asia-Pacific region, particularly China and South Korea, has emerged as a leading hub for TPD research, with multiple companies advancing candidates through late-stage clinical trials. - The global TPD market is projected to surge from $1 billion currently to $6.94 billion by 2035, driven by advances in computational tools and AI-enabled drug design.
- LEO Pharma announced positive 16-week interim results from the phase 3b ADHAND trial, with tralokinumab meeting all primary and secondary endpoints for moderate to severe atopic dermatitis on the hands. - The IL-13 targeting monoclonal antibody showed statistically significant improvements in skin clearance, itch and pain reduction, and severity scores compared to placebo. - More than 50% of patients with moderate-to-severe atopic dermatitis have hand involvement, representing a significant unmet medical need in this difficult-to-treat area. - The treatment was generally well-tolerated with no new safety signals identified, with most adverse events being non-serious and mild to moderate in severity.
