About Us

Nirsum Laboratories, Inc. is a CNS-focused clinical-stage biotech company, with lead asset NRS-033 entering Phase 2 clinical development. The drug is an internally discovered, patented, wholly owned, long-acting injectable µ-opioid receptor antagonist – a well validated mechanism of action – being developed for opioid and alcohol use disorder (OUD and AUD, respectively). The US prevalence of OUD and AUD is 9.4 million and 30 million, respectively. Both conditions are amongst the largest public health problems in the US. AUD has been a public health problem for decades, worsened by the isolation of the Covid era. The OUD crisis emerged in the early 2000s initiated by prescription opioid overprescribing, now primarily driven by fentanyl abuse. Unfortunately, only three decades-old and problem-laden therapeutics are FDA approved for each of these indications. These therapeutics have had limited uptake due to low adherence and retention, burdensome side effects, abuse liability, and/or restricted distribution. As a result, OUD and AUD remain severely unmet medical needs, with US therapeutic market penetration into AUD of ~2% and into abstinence-seeking (after detoxification) OUD of ~5%. As a result, relapse rates in AUD and OUD are up to ~60% and ~91%, respectively.

Such dire outcomes reinforce the stigma of OUD and AUD as moral failings, rather than as treatable disease of biologic origin. Similarly misplaced stigmas were once prevalent for other diseases: HIV was initially cast as God’s wrath upon the sinful until the mid-’90s, when adherence-friendly regimens began normalizing life expectancy; major depression was viewed as a character infirmity until tolerable SSRIs (e.g., fluoxetine) in 1987 began popularizing treatment; psychotic patients were once quarantined in “insane asylums”, and even lobotomized, before tolerable atypical antipsychotics (e.g., clozapine) in 1989 revolutionized care; and, until 2021 obese patients were cast as indulgent and undisciplined, until weekly 2nd generation GLP-1 agonists (e.g., semaglutide) displaced less effective and unpopular daily dosed 1st generation GLP-1 agonist liraglutide. In each case, therapeutic innovation helped de-stigmatize the disease, driving millions to seek care. Similarly, Nirsum believes NRS-033 will change today’s bleak narrative of addiction to one of hope and recovery.