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Arcturus Therapeutics

  (Redirected from Alcobra)

Arcturus Therapeutics is a preclinical drug delivery and RNA medicines company. The company is focused on the development of UNA Oligomer chemistry and LUNAR® lipid-mediated delivery.

Arcturus Therapeutics
Public company
IndustryPharmaceutical industry
Founded2013; 6 years ago (2013)
HeadquartersSan Diego, CA, US
ProductsMetadoxine Extended Release (MDX); Abuse Deterrent Amphetamine Immediate Release (ADAIR)

Arcturus Therapeutics is headquartered in San Diego, CA, US.


Company historyEdit

Founded in 2013 and based in San Diego, Arcturus Therapeutics Ltd. (NASDAQ:ARCT) is an RNA medicines company with enabling technologies – UNA Oligomer chemistry and LUNAR® lipid-mediated delivery. In November 2017, Arcturus merged with Alcobra, an Israeli-based Biotech company focused on the development of new medications to help patients with cognitive disorders, including attention deficit hyperactivity disorder (ADHD) and fragile X syndrome.[1]

Products in developmentEdit

Metadoxine Extended Release (MDX) is the company’s lead investigational product candidate. Metadoxine Extended Release is a monoamine-independent modulator of GABA (gamma-aminobutyric acid) transmission. The mechanism of action does not directly affect dopamine or norepinephrine. The compound is not a psychostimulant. Metadoxine has shown no potential for abuse or addiction in studies completed to date.[2]


Alcobra has completed two Phase II trials[3][4] and one Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD.[5] Alcobra has also completed one Phase II adolescent ADHD study of Metadoxine Extended Release (MDX).[6] In mid-2015, Alcobra began a second Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD, called the MEASURE study.

Fragile X syndromeEdit

In December 2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment of fragile X syndrome.[7] In June 2015, Alcobra completed a Phase II clinical trial of MDX for the treatment of adolescents and adults with fragile X syndrome.[8] In September 2015, the FDA granted “Fast Track” status to Metadoxine Extended Release (MDX) for fragile X syndrome.[9]


  1. ^ Inc., Arcturus Therapeutics,. "Arcturus Therapeutics Announces Completion of Merger with Alcobra Ltd. and Commences Trading on the Nasdaq Global Market". GlobeNewswire News Room. Retrieved 2018-05-06.
  2. ^ "Metadoxine extended release (MDX) for adult ADHD". Alcobra Ltd. 2014. Retrieved 2014-05-07.
  3. ^ Manor, I; Ben-Hayun R; Aharon-Peretz J; Salomy D; Weizman A; Daniely Y; Meggido D; Newcorn JH; Biederman J; Adler LA (2013). "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Metadoxine in Adults with Attention-Deficit/Hyperactivity Disorder". Journal of Clinical Psychiatry. 73: 1517–1523. doi:10.4088/jcp.12m07767. PMID 23290324.
  4. ^ Manor, I; Rubin J; Daniely Y; Adler LA (2014). "Attention Benefits After a Single Dose of Metadoxine Extended Release in Adults with Predominantly Inattentive ADHD". Postgrad Med. 126: 7–16. doi:10.3810/pgm.2014.09.2795. PMID 25295645.
  5. ^ Weisler, R; Adler LA; Rubin J; Daniely Y; Manor I (2014). "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Metadoxine Extended Release 1400 mg Compared with Placebo Once Daily in 300 Adults with Attention-Deficit/Hyperactivity Disorder". Missing or empty |url= (help)
  6. ^ "Alcobra's MDX Meets Primary Endpoint in Phase II Safety and Tolerability Clinical Trial in Adolescents With ADHD". Alcobra Ltd. 2015. Retrieved 2015-03-10.
  7. ^ "FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome". Alcobra Ltd. 2013. Retrieved 2013-12-18.
  8. ^ "Alcobra announces results from Phase 2 clinical trial of MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-06-24.
  9. ^ "FDA grants fast track designation to Alcobra's MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-09-21.