DNL-788 is under clinical development by Denali Therapeutics and currently in Phase II for Secondary Progressive Multiple Sclerosis (SPMS). According to GlobalData, Phase II drugs for Secondary Progressive Multiple Sclerosis (SPMS) have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how DNL-788’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.

DNL-788 overview

DNL-788 is under development for the treatment of Alzheimer’s disease, amyotrophic lateral sclerosis (ALS) and primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS) and relapsing remitting multiple sclerosis (RRMS). It is administered orally in form of tablet. The drug candidate is a brain-penetrant small molecule and acts by targeting receptor interacting serine/threonine protein kinase1 (RIPK1).

Denali Therapeutics overview

Denali Therapeutics, is a clinical-stage bio-pharmaceutical company that focuses on the development of therapeutics for the treatment of neurodegenerative diseases. Its proprietary drug delivery platform technologies include antibody transport vehicle and enzyme transport vehicle designed to deliver large molecules across the blood-brain barrier (BBB). Its pipeline products are intended for the treatment of Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease, multiple system atrophy, lysosomal storage disorder MPS II, neurodegeneration, amyotrophic lateral sclerosis and other indications. The company’s product pipeline include DNL201, DNL151, ATV:aSyn, for Parkinson’s disease, DNL747, ATV:Tau, ATV:TREM2, for Alzheimer’s disease; and CH1 and LF1, for neurodegeneration. It has development and commercialization rights to all of its programs, including the programs partnered with Takeda. The company has its operations in the UK and the US. Denali Therapeutics is headquartered in San Francisco, California, the US.

For a complete picture of DNL-788’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.