This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, corticotropin releasing hormone, and interferon-alpha. These drugs are administered via the subcutaneous, intravenous, intramuscular, and oral routes.
• The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II. Therapies in development for SLE focus on a wide variety of targets. The largest proportion of pipeline drugs are administered via the subcutaneous route, with the remainder being intravenous, oral, and intramuscular formulations.
• High-impact upcoming events for drugs in the SLE space comprise topline Phase II trial results for lenabasum, iscalimab, and BMS-986165; topline Phase IIb trial results for cenerimod; topline Phase III trial results for Benlysta, Olumiant, Saphnelo, and dapirolizumab pegol; an expected patent expiration for INV103; and estimated CHMP filing results for Saphnelo.
• The overall likelihood of approval of a Phase I SLE asset is 4.8%, and the average probability a drug advances from Phase III is 45.5%. Drugs, on average, take 10.8 years from Phase I to approval, compared to 9.3 years in the overall autoimmune/immunology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for SLE have been in the early and midphases of development, with 68% of trials in Phase I–II, and 32% in Phase III–IV.
• The US has a substantial lead in the number of SLE clinical trials globally. Germany leads the major European markets, while South Korea has the top spot in Asia.
• Clinical trial activity in the SLE space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for SLE, with 31 trials.
• GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.