Lumateperone: First Approval

@article{Blair2020LumateperoneFA,
  title={Lumateperone: First Approval},
  author={Hannah A. Blair},
  journal={Drugs},
  year={2020},
  volume={80},
  pages={417-423}
}
Lumateperone (Caplyta ® ) is a novel, orally available agent developed by Intra-Cellular Therapies (under a license from Bristol-Myers Squibb) for the treatment of schizophrenia and other neuropsychiatric and neurological disorders. Lumateperone is a first-in-class selective and simultaneous modulator of serotonin, dopamine and glutamate. In December 2019, lumateperone received its first global approval in the USA for the treatment of schizophrenia in adults. The drug is also under clinical… 
Evidence On The New Drug Lumateperone (Iti-007) For Psychiatric And Neurological Disorders.
TLDR
Lumateperone represents a new potential option for other psychiatric and neurological diseases, such as behavioural symptoms of dementia or Alzheimer's Disease, sleep disturbances, bipolar depression, and potential future role of this particular compound in personalized treatments.
Lumateperone for the Treatment of Adults With Schizophrenia: a Systematic Review
TLDR
Results indicate that LUM significantly improves symptoms severity in adults withSCZ and should be conceptualized as a first-line treatment strategy for adults with SCZ.
Atypical Antipsychotic Lumateperone Effects on the Adrenal Gland With Possible Beneficial Effect of Quercetin Co-administration
TLDR
Quercetin had a prophylactic effect against lumateperone depressive-like effect on animal behavior and its possible adrenal damage, and coadministration of quercet in and lumatesperone showed improvement of the previously deteriorated parameters.
Lumateperone tosylate, A Selective and Concurrent Modulator of Serotonin, Dopamine, and Glutamate, in the Treatment of Schizophrenia.
TLDR
The background, evidence, and indications for the use of lumateperone tosylate in the treatment of schizophrenia are presented, and the most common adverse effects are shown to be mild such as somnolence, constipation, sedation, and fatigue.
Drug–drug interactions involving antipsychotics and antihypertensives
TLDR
The current knowledge is sufficiently strong to guide clinicians in selecting safer drug combinations as summarized here to provide the clinician an insight into the pharmacokinetic and pharmacodynamic interactions between these drugs.
Up-to-date expert opinion on the safety of recently developed antipsychotics
TLDR
Overall, newer antipsychotic medications display a good safety profile, with a well-demonstrated lower metabolic liability compared to second-generation antipsychotics, and appear to specifically target negative symptomatology and improving cognitive domains.
New Antipsychotic Medications in the Last Decade
TLDR
Last decade has seen a tremendous development in second-generation antipsychotics which provides unprecedented treatment options for clinicians in treating psychosis.
Tailor-made amino acid-derived pharmaceuticals approved by the FDA in 2019.
TLDR
This review article profiles 13 new tailor-made AA-derived pharmaceuticals introduced to the market in 2019, and discusses the development form drug-candidates, total synthesis, with emphasis on the core-AA, therapeutic area, and the mode of biological activity.
...
...

References

SHOWING 1-10 OF 29 REFERENCES
Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial.
TLDR
The results suggest that lumateperone 42 mg may be a promising new treatment for bipolar depression associated with bipolar I or bipolar II disorder.
F46. LUMATEPERONE (ITI-007): FAVORABLE SAFETY PROFILE IN AN OPEN LABEL SAFETY SWITCHING STUDY FROM STANDARD-OF-CARE ANTIPSYCHOTIC THERAPY IN PATIENTS WITH SCHIZOPHRENIA
TLDR
The lack of metabolic, motor and cardiovascular safety issues presents a safety profile differentiated from standard-of-care antipsychotic therapy, and patients with stable symptoms on other antipsychotics may further improve when switched to lumateperone, with no dose titration needed.
30 Lumateperone (ITI-007) for the Treatment of Schizophrenia: Overview of Placebo-Controlled Clinical Trials and an Open-label Safety Switching Study
TLDR
Lumateperone improved symptoms of schizophrenia with the same trajectory and same magnitude of improvement from baseline to endpoint on the PANSS total score, and was well-tolerated with a favorable safety profile in all studies.
Dopamine D2 receptor occupancy of lumateperone (ITI-007): a Positron Emission Tomography Study in patients with schizophrenia
TLDR
D2RO at plasma steady state of 60 mg ITI-007, a dose that previously demonstrated antipsychotic efficacy in a controlled trial, was determined and likely contributes to the favorable safety and tolerability profile of lumateperone with reduced risk for movement disorders and hyperprolactinemia.
Functional profile of a novel modulator of serotonin, dopamine, and glutamate neurotransmission
TLDR
The combination of in vitro and in vivo activities of this compound support its development for the treatment of schizophrenia and other psychiatric and neurologic disorders.
Efficacy and Safety of Lumateperone for Treatment of Schizophrenia
This randomized clinical trial examines the efficacy and safety of lumateperone for the short-term treatment of adults with schizophrenia.
ITI-007/ITI-722: a new approach for the treatment of sleep maintenance insomnia and sleep disorders associated with psychiatric and neurological diseases [abstract
  • Sleep. 2009;32(Suppl S):A284–5
  • 2009
Additional results from a 12-month open-label safety study of lumateperone (ITI-007) in patients with stable symptoms of schizophrenia [abstract no. W203 plus poster
  • Annual Meeting of the American College of Neuropsychopharmacology
  • 2019
Lumateperone (ITI-007): favorable safety profile in an open label safety switching study from standard-of-care antipsychotic therapy in patients with schizophrenia [abstract no. F46
  • Schizophr Bull. 2018;44(Suppl 1):S236–7
  • 2018
...
...