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Fasoracetam was discovered by scientists at the Japanese pharmaceutical company [[Nippon Shinyaku]], which brought it through [[phases of clinical research|Phase 3 clinical trials]] for [[vascular dementia]], and abandoned it due to lack of [[efficacy]].<ref name=Connolly>{{cite journal |title=ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder. | volume=49 | issue=5 | journal=Ther Innov Regul Sci | pages=632–642 | last1 = Connolly| first1 = J | last2 = Glessner | first2 = J | last3 = Kao | first3 = C | last4 = Elia | first4 = J | last5 = Hakonarson | first5 = H | year=2015 | doi=10.1177/2168479015599811|pmid=26366330|pmc=4564067}}</ref><ref name=Hoskowitz>{{cite book|last1=Moskowitz|first1=D. H.|title=Finding the Genetic Cause and Therapy for ADHD, Autism and 22q|date=2017|publisher=BookBaby (self published)|isbn=9781483590981|url=https://books.google.com/books?id=LSrlDQAAQBAJ&pg=PT117|language=en}}</ref>
Fasoracetam was discovered by scientists at the Japanese pharmaceutical company [[Nippon Shinyaku]], which brought it through [[phases of clinical research|Phase 3 clinical trials]] for [[vascular dementia]], and abandoned it due to lack of [[efficacy]].<ref name=Connolly>{{cite journal |title=ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder. | volume=49 | issue=5 | journal=Ther Innov Regul Sci | pages=632–642 | last1 = Connolly| first1 = J | last2 = Glessner | first2 = J | last3 = Kao | first3 = C | last4 = Elia | first4 = J | last5 = Hakonarson | first5 = H | year=2015 | doi=10.1177/2168479015599811|pmid=26366330|pmc=4564067}}</ref><ref name=Hoskowitz>{{cite book|last1=Moskowitz|first1=D. H.|title=Finding the Genetic Cause and Therapy for ADHD, Autism and 22q|date=2017|publisher=BookBaby (self published)|isbn=9781483590981|url=https://books.google.com/books?id=LSrlDQAAQBAJ&pg=PT117|language=en}}</ref>


Scientists at [[Children's Hospital of Philadelphia]] led by Hakon Hakonarson have studied fasoracetam's potential use in [[attention deficit hyperactivity disorder]].<ref name=Connolly/> Hakonarson started a company called neuroFix Therapeutics to try to bring the drug to market for this use; neuroFix acquired Nippon Shinyaku's clinical data as part of its efforts.<ref name=Hoskowitz/><ref name=Alpha/> neuroFix was acquired by Medgenics in 2015.<ref name=Alpha/> Medgenics changed its name to Aevi Genomic Medicine in 2016.<ref>{{cite web | title=Press Release: Medgenics, Inc. Announces Name Change to Aevi Genomic Medicine, Inc. | url=http://www.prnewswire.com/news-releases/medgenics-inc-announces-name-change-to-aevi-genomic-medicine-inc-300378599.html | publisher=Aevi via MarketWired|date=16 December 2016}}</ref> Clinical trials in adolescents with ADHD who also have mGluR mutations started in 2016.<ref name=Alpha>{{cite news | title=Medgenics: NFC-1 Could Be A Key Future Revenue Driver. | url=https://seekingalpha.com/article/4010894-medgenics-nfcminus-1-key-future-revenue-driver | author=Sharma, B.| newspaper=Seeking Alpha | date=7 October 2016 }}</ref> While Fasoracetam may be effective in the treatment of ADHD in people with specific mGluR mutations, these represent around 10% of total ADHD cases, and Fasoracetam is likely ineffective in all other cases..<ref name="pmid29339723"/><ref>{{Cite web|last=Tardner|first=P|title=Fasoracetam as a treatment for ADHD: A systematic review of available clinical data|url=https://www.ijest.org/fasoracetam-treatment-adhd-a-systematic-review/|date=2020-09-09|journal=International Journal of Environmental Science & Technology|language=en-US}}</ref> Studies showing improvements in cognitive function from Fasoracetam have exclusively been done on rodents.<ref name="pmid29339723">{{Cite journal|last1=Elia|first1=Josephine|last2=Ungal|first2=Grace|last3=Kao|first3=Charlly|last4=Ambrosini|first4=Alexander|last5=De Jesus-Rosario|first5=Nilsa|last6=Larsen|first6=Lene|last7=Chiavacci|first7=Rosetta|last8=Wang|first8=Tiancheng|last9=Kurian|first9=Christine|last10=Titchen|first10=Kanani|last11=Sykes|first11=Brian|date=2018-01-16|title=Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling|journal=Nature Communications|volume=9|issue=1|page=4|doi=10.1038/s41467-017-02244-2|issn=2041-1723|pmc=5770454|pmid=29339723|bibcode=2018NatCo...9....4E}}</ref>
Scientists at [[Children's Hospital of Philadelphia]] led by Hakon Hakonarson have studied fasoracetam's potential use in [[attention deficit hyperactivity disorder]].<ref name=Connolly/> Hakonarson's company neuroFix tried to bring the drug to market for this use; neuroFix acquired Nippon Shinyaku's clinical data as part of its efforts.<ref name=Hoskowitz/><ref name=Alpha/> neuroFix was acquired by Medgenics in 2015.<ref name=Alpha/> Medgenics changed its name to Aevi Genomic Medicine in 2016.<ref>{{cite web | title=Press Release: Medgenics, Inc. Announces Name Change to Aevi Genomic Medicine, Inc. | url=http://www.prnewswire.com/news-releases/medgenics-inc-announces-name-change-to-aevi-genomic-medicine-inc-300378599.html | publisher=Aevi via MarketWired|date=16 December 2016}}</ref>
Clinical trials in adolescents with ADHD who also have mGluR mutations started in 2016.<ref name=Alpha>{{cite news | title=Medgenics: NFC-1 Could Be A Key Future Revenue Driver. | url=https://seekingalpha.com/article/4010894-medgenics-nfcminus-1-key-future-revenue-driver | author=Sharma, B.| newspaper=Seeking Alpha | date=7 October 2016 }}</ref> While Fasoracetam may be effective in the treatment of ADHD in people with specific mGluR mutations, these represent around 10% of total ADHD cases, and Fasoracetam is likely ineffective in all other cases.<ref name="pmid29339723"/><ref>{{Cite web|last=Tardner|first=P|title=Fasoracetam as a treatment for ADHD: A systematic review of available clinical data|url=https://www.ijest.org/fasoracetam-treatment-adhd-a-systematic-review/|date=2020-09-09|journal=International Journal of Environmental Science & Technology|language=en-US}}</ref> Studies showing improvements in cognitive function from Fasoracetam have exclusively been done on rodents.<ref name="pmid29339723">{{Cite journal|last1=Elia|first1=Josephine|last2=Ungal|first2=Grace|last3=Kao|first3=Charlly|last4=Ambrosini|first4=Alexander|last5=De Jesus-Rosario|first5=Nilsa|last6=Larsen|first6=Lene|last7=Chiavacci|first7=Rosetta|last8=Wang|first8=Tiancheng|last9=Kurian|first9=Christine|last10=Titchen|first10=Kanani|last11=Sykes|first11=Brian|date=2018-01-16|title=Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling|journal=Nature Communications|volume=9|issue=1|page=4|doi=10.1038/s41467-017-02244-2|issn=2041-1723|pmc=5770454|pmid=29339723|bibcode=2018NatCo...9....4E}}</ref>


== Legality ==
== Legality ==

Revision as of 22:30, 2 September 2023

Fasoracetam
Names
IUPAC name
(5R)-5-(Piperidine-1-carbonyl)pyrrolidin-2-one
Other names
(5R)-5-Oxo-D-prolinepiperidinamide monohydrate, NS-105, AEVI-001, LAM 105, MDGN-001, NFC 1[1][2]
Identifiers
3D model (JSmol)
ChEMBL
ChemSpider
KEGG
UNII
  • InChI=1S/C10H16N2O2/c13-9-5-4-8(11-9)10(14)12-6-2-1-3-7-12/h8H,1-7H2,(H,11,13)/t8-/m1/s1 checkY
    Key: GOWRRBABHQUJMX-MRVPVSSYSA-N checkY
  • InChI=1/C10H16N2O2/c13-9-5-4-8(11-9)10(14)12-6-2-1-3-7-12/h8H,1-7H2,(H,11,13)/t8-/m1/s1
    Key: GOWRRBABHQUJMX-MRVPVSSYBL
  • O=C(N1CCCCC1)[C@@H]2NC(=O)CC2
Properties
C10H16N2O2
Molar mass 196.250 g·mol−1
Pharmacology
Oral
Legal status
  • AU: S4 (Prescription only)
  • US: Not FDA approved
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
☒N verify (what is checkY☒N ?)

Fasoracetam is a research chemical of the racetam family.[3] It is a putative nootropic that failed to show sufficient efficacy in clinical trials for vascular dementia. It is currently being studied for its potential use for attention deficit hyperactivity disorder.[2][4]

Fasoracetam appears to agonize all three groups of metabotropic glutamate receptors and has improved cognitive function in rodent studies.[5] It is orally bioavailable and is excreted mostly unchanged via the urine.[6]

Fasoracetam was discovered by scientists at the Japanese pharmaceutical company Nippon Shinyaku, which brought it through Phase 3 clinical trials for vascular dementia, and abandoned it due to lack of efficacy.[5][7]

Scientists at Children's Hospital of Philadelphia led by Hakon Hakonarson have studied fasoracetam's potential use in attention deficit hyperactivity disorder.[5] Hakonarson's company neuroFix tried to bring the drug to market for this use; neuroFix acquired Nippon Shinyaku's clinical data as part of its efforts.[7][8] neuroFix was acquired by Medgenics in 2015.[8] Medgenics changed its name to Aevi Genomic Medicine in 2016.[9]

Clinical trials in adolescents with ADHD who also have mGluR mutations started in 2016.[8] While Fasoracetam may be effective in the treatment of ADHD in people with specific mGluR mutations, these represent around 10% of total ADHD cases, and Fasoracetam is likely ineffective in all other cases.[10][11] Studies showing improvements in cognitive function from Fasoracetam have exclusively been done on rodents.[10]

Legality

Australia

Fasoracetam is a schedule 4 substance in Australia under the Poisons Standard (February 2020).[12] A schedule 4 substance is classified as "Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription."[12]

See also

References

  1. ^ FDA/NIH Substance registration system. Page accessed March 21, 2016
  2. ^ a b "Drug Profile Fasoracetam".
  3. ^ "5-oxo-D-prolinepiperidinamide monohydrate - Compound Summary". Retrieved 21 July 2013.
  4. ^ "Recommended INN List 40" (PDF). WHO Drug Information. 12 (2). 1998.
  5. ^ a b c Connolly, J; Glessner, J; Kao, C; Elia, J; Hakonarson, H (2015). "ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder". Ther Innov Regul Sci. 49 (5): 632–642. doi:10.1177/2168479015599811. PMC 4564067. PMID 26366330.
  6. ^ Malykh, AG; Sadaie, MR (12 February 2010). "Piracetam and piracetam-like drugs: from basic science to novel clinical applications to CNS disorders". Drugs. 70 (3): 287–312. doi:10.2165/11319230-000000000-00000. PMID 20166767. S2CID 12176745.
  7. ^ a b Moskowitz, D. H. (2017). Finding the Genetic Cause and Therapy for ADHD, Autism and 22q. BookBaby (self published). ISBN 9781483590981.
  8. ^ a b c Sharma, B. (7 October 2016). "Medgenics: NFC-1 Could Be A Key Future Revenue Driver". Seeking Alpha.
  9. ^ "Press Release: Medgenics, Inc. Announces Name Change to Aevi Genomic Medicine, Inc". Aevi via MarketWired. 16 December 2016.
  10. ^ a b Elia, Josephine; Ungal, Grace; Kao, Charlly; Ambrosini, Alexander; De Jesus-Rosario, Nilsa; Larsen, Lene; Chiavacci, Rosetta; Wang, Tiancheng; Kurian, Christine; Titchen, Kanani; Sykes, Brian (2018-01-16). "Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling". Nature Communications. 9 (1): 4. Bibcode:2018NatCo...9....4E. doi:10.1038/s41467-017-02244-2. ISSN 2041-1723. PMC 5770454. PMID 29339723.
  11. ^ Tardner, P (2020-09-09). "Fasoracetam as a treatment for ADHD: A systematic review of available clinical data". International Journal of Environmental Science & Technology.
  12. ^ a b Poisons Standard February 2020. comlaw.gov.au
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