Nbi1117568
Indications under investigation:
schizophrenia, cognitive disorder

NBI-1117568: A Promising Treatment for Schizophrenia

NBI-1117568 is an oral, selective muscarinic M4 receptor agonist being developed primarily for the treatment of schizophrenia and other neuropsychiatric disorders. The drug is currently in Phase 2 clinical trials and has shown promise in targeting cognitive and psychotic symptoms associated with schizophrenia [source, source].

Competitive Landscape

  • NBI-1117568 is part of a growing field of muscarinic receptor agonists aimed at treating schizophrenia and related disorders. Other drugs in this category include KarXT and emraclidine, which are also in various stages of clinical development [source].

Key Advantages

  • Selectivity: NBI-1117568 is highly selective for the M4 receptor, which may reduce the risk of side effects associated with non-selective muscarinic agonists [source].
  • Efficacy: The drug has shown potential in treating both positive and negative symptoms of schizophrenia, which are often challenging to manage with existing treatments [source].

Main Issues

  • Side Effects: Common side effects include headache, worsening of schizophrenia, insomnia, and anxiety. Serious adverse events have also been reported, although they are relatively rare [source].
  • Long-term Safety: While the drug has successfully completed a long-term preclinical toxicity program, its long-term safety in humans remains to be fully established [source].

Treatment guidelines

Recent transactions

Type
licensing
Buyer
Neurocrine Biosciences
Seller
Sosei Group Corporation
Deal size
Assets
NBI-1117568
Date
2022-10-27
Source
Type
licensing
Buyer
Neurocrine Biosciences
Seller
Sosei Heptares
Deal size
$2.60B
Assets
NBI-1117568
Date
2022-09-01
Source
Type
licensing
Buyer
Neurocrine Biosciences
Seller
Sosei Group Corporation
Deal size
$2.60B
Assets
NBI-1117568
Date
2022-08-05
Source

Indications

Indication
schizophrenia
Preclinical
Phase 1
Phase 2
Phase 3
Approved
Phase 4

Trials

Net present value

Assumptions
Population (M)
Prevalence (/100k)
Launch time
Exclusivity years
Years to peak penetration
Market share (%)
Price per treatment
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Timeline
Completion of NCT05545111
2024-12-01
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Neurocrine Biosciences Q1 2024 Financial Results
2024-05-01
Neurocrine Biosciences reported a 23% year-over-year growth in INGREZZA's first-quarter sales. The company has submitted New Drug Applications for crinecerfont and reported positive Phase 2 results for NBI-1065845. Neurocrine Biosciences reaffirmed its 2024 net sales guidance and updated its expense guidance.
Nxera's schizophrenia drug progresses successfully
2024-04-16
NBI-1117568, a schizophrenia drug candidate partnered between Nxera Pharma and Neurocrine Biosciences, has successfully completed long-term preclinical toxicity studies. The achievement triggers a $15 million payment to Nxera from Neurocrine. Top-line Phase 2 data for NBI-1117568 is expected in the second half of 2024.
NBI-1117568 achieves safety milestone
2024-04-16
Nxera Pharma's partner Neurocrine Biosciences has successfully completed a long-term preclinical toxicity program for NBI-1117568, triggering a $15 million payment to Nxera. NBI-1117568 is an oral selective muscarinic M4 receptor agonist in Phase 2 clinical trials for schizophrenia and other neuropsychiatric disorders. The successful completion of this safety milestone supports the potential for safe, long-term use of NBI-1117568 in patients with schizophrenia and other neurological diseases.
Neurocrine Biosciences Financial Results
2024-02-07
Neurocrine Biosciences reported strong financial results for Q4 and FY 2023, with significant growth in INGREZZA sales. The company provided optimistic financial guidance for 2024, expecting INGREZZA sales to reach $2.1 - $2.2 billion. Neurocrine Biosciences anticipates submitting a New Drug Application for Crinecerfont to the FDA in Q2 2024.