Overview
Piracetam is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid and is a cyclic derivative of the neurotransmitter γ-aminobutyric acid (GABA). However its mechanism of action differ from that of endogenous GABA. Piracetam has neuroprotective and anticonvulsant properties and is reported to improve neural plasticity . Its efficacy is documented in cognitive disorders and dementia, vertigo, cortical myoclonus, dyslexia, and sickle cell anemia although the clinical application in these conditions is not yet established. Piracetam has effects on the vascular system by reducing erythrocyte adhesion to the vascular endothelium, hindering vasospasms and facilitating microcirculation . Originally marketed by UCB Pharma in 1971, piracetam was the first nootropic drug to modulate cognitive function without causing sedation or stimulation . It is not approved for any medical or dietary use by the FDA. In the UK, piracetam is prescribed mainly for myoclonus, but is used off-label for other conditions such as learning difficulties in children, memory loss or other cognitive defects in the elderly, and sickle-cell vaso-occlusive crises . Evidence to support its use for many conditions is unclear.
Background
Piracetam is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid and is a cyclic derivative of the neurotransmitter γ-aminobutyric acid (GABA). However its mechanism of action differ from that of endogenous GABA. Piracetam has neuroprotective and anticonvulsant properties and is reported to improve neural plasticity . Its efficacy is documented in cognitive disorders and dementia, vertigo, cortical myoclonus, dyslexia, and sickle cell anemia although the clinical application in these conditions is not yet established. Piracetam has effects on the vascular system by reducing erythrocyte adhesion to the vascular endothelium, hindering vasospasms and facilitating microcirculation . Originally marketed by UCB Pharma in 1971, piracetam was the first nootropic drug to modulate cognitive function without causing sedation or stimulation . It is not approved for any medical or dietary use by the FDA. In the UK, piracetam is prescribed mainly for myoclonus, but is used off-label for other conditions such as learning difficulties in children, memory loss or other cognitive defects in the elderly, and sickle-cell vaso-occlusive crises . Evidence to support its use for many conditions is unclear.
Indication
Indicated in adult patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies .
Associated Conditions
- Alcohol Dependency
- Alcohol Withdrawal Syndrome
- Cognitive Deficits caused by Injuries, Craniocerebral
- Cognitive Dysfunctions
- Cognitive Impairment (CI)
- Comatose caused by Blood Vessel (Vascular) Dysfunction
- Comatose caused by CNS Toxicity
- Comatose caused by Traumas
- Learning Disorders
- Myoclonus
- Sickle Cell Disease (SCD)
- Giddiness caused by Injuries, Craniocerebral
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/06/28 | Phase 4 | Not yet recruiting | |||
2023/06/26 | Phase 4 | Not yet recruiting | |||
2015/03/02 | Phase 3 | Terminated | |||
2013/06/21 | Phase 4 | Terminated | UCB S.A. - Pharma Sector | ||
2007/12/04 | Not Applicable | Completed | |||
2005/09/19 | Phase 3 | Completed | Beersheva Mental Health Center | ||
1999/09/21 | Phase 1 | Withdrawn | |||
1999/09/21 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
CEBROTONIN TABLET 800 mg | SIN06408P | TABLET, FILM COATED | 800 mg | 7/4/1991 | |
NOOTROPIL TABLET 1200 mg | SIN08988P | TABLET, FILM COATED | 1200.00 mg | 11/2/1996 | |
NEUROCETAM CAPSULE 400 mg | SIN08477P | CAPSULE | 400 mg | 12/13/1995 | |
NOOTROPIL TABLET 800 mg | SIN00574P | TABLET, FILM COATED | 800.00 mg | 4/29/1988 | |
CETAM CAPSULE 400 mg | SIN10602P | CAPSULE | 400 mg | 1/6/1999 | |
RACETAM CAPSULE 400 mg (Orange/white) | SIN10738P | CAPSULE | 400 mg | 2/11/1999 | |
CETAM INJECTION 200MG/ML | SIN16054P | INJECTION | 200MG/ML | 11/30/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Piracetam for Injection | 国药准字H20050356 | 化学药品 | 注射剂 | 9/16/2023 | |
Piracetam for Injection | 国药准字H20050358 | 化学药品 | 注射剂 | 9/16/2023 | |
Piracetam for Injection | 国药准字H20040004 | 化学药品 | 注射剂 | 8/11/2020 | |
Piracetam for Injection | 国药准字H20158006 | 化学药品 | 注射剂 | 10/22/2020 | |
Piracetam for Injection | 国药准字H20041871 | 化学药品 | 注射剂 | 9/21/2020 | |
Piracetam for Injection | 国药准字H20041637 | 化学药品 | 注射剂 | 2/23/2021 | |
Piracetam for Injection | 国药准字H20050638 | 化学药品 | 注射剂 | 5/28/2020 | |
Piracetam for Injection | 国药准字H20056840 | 化学药品 | 注射剂 | 8/13/2020 | |
Piracetam for Injection | 国药准字H20041771 | 化学药品 | 注射剂(冻干粉针剂) | 3/30/2020 | |
Piracetam for Injection | 国药准字H20050200 | 化学药品 | 注射剂 | 8/4/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
NOOTROPIL FILM-COATED TAB 800MG | N/A | N/A | N/A | 3/5/1985 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |