Vamorolone is under clinical development by Santhera Pharmaceuticals and currently in Pre-Registration for Duchenne Muscular Dystrophy. According to GlobalData, Pre-Registration drugs for Duchenne Muscular Dystrophy have an 83% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Vamorolone’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Vamorolone overview

Vamorolone (VBP-15) is under development for the treatment of mild or moderately active ulcerative colitis, Duchenne muscular dystrophy (DMD), Becker muscular dystrophy, asthma, chronic obstructive pulmonary disorder, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, ANCA-associated vasculitis, juvenile dermatomyositis, calpain 3 deficiency (LGMD2A), limb girdle muscular dystrophy type 2B (LGMD2B) and was under development for the treatment of sickle cell anemia, cystic fibrosis and systemic juvenile idiopathic arthritis (SJIA). It is administered orally as suspension. Vamorolone is a dissociative delta-9, 11 glucocorticoid analogue, a steroidal drug. It targets NR3C1.

Santhera Pharmaceuticals overview

Santhera Pharmaceuticals (Santhera) develops and markets novel pharmaceutical products indicated for patients with mitochondrial and neuromuscular diseases. The company specifically focuses on the area of neuromuscular and ophthalmological conditions. The company’s lead product candidate, Raxone is developed for the treatment of Leber’s hereditary optic neuropathy (LHON) and is approved by the European Marketing Authorization. Raxone is investigated for other diseases such as Duchenne muscular dystrophy and primary progressive multiple sclerosis. Santhera’s pipeline also includes other compounds, namely, omigapil for congenital muscular dystrophies. It operates through its subsidiaries in Switzerland, Liechtenstein, Germany, Canada, the UK, Italy, the Netherlands, and the US. Santhera is headquartered in Pratteln, Switzerland.

For a complete picture of Vamorolone’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 15 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.