Overview
GDC-0084 is under investigation in clinical trial NCT03696355 (Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Paxalisib (GDC-0084): A Brain-Penetrant PI3K/mTOR Inhibitor for CNS Malignancies
1. Introduction to Paxalisib (GDC-0084)
1.1. Overview and Chemical Identity
Paxalisib, an investigational small molecule drug, is also identified by its developmental code name GDC-0084 and synonym RG7666.[1] It is cataloged in DrugBank with the Accession Number DB15186.[1] The Chemical Abstracts Service (CAS) Number for Paxalisib is 1382979-44-3.[1]
The IUPAC name for Paxalisib is 5-(6,6-dimethyl-4-morpholin-4-yl-8,9-dihydropurino[8,9-c]\oxazin-2-yl)pyrimidin-2-amine.[1] An alternative chemical name is 5-(6,6-Dimethyl-4-morpholino-8,9-dihydro-6H-\oxazino[4,3-e]purin-2-yl)pyrimidin-2-amine.[3] Paxalisib has a molecular formula of C18H22N8O2, corresponding to an average molecular weight of 382.428 g/mol and a monoisotopic mass of 382.18657198 Da.[1]
The presence of multiple identifiers such as GDC-0084 and RG7666, alongside the formally adopted name Paxalisib (USAN/INN), reflects the typical progression of a drug through distinct research and development phases. GDC-0084 was likely Genentech's internal research designation during its early discovery and development. As a compound advances into more formal clinical development and towards potential commercialization, it receives an official non-proprietary name like Paxalisib, which is recognized globally by regulatory authorities and in scientific literature.[1] This nomenclature evolution is a standard practice in the pharmaceutical industry, marking the transition from an early-stage research compound to a more mature clinical candidate.
Table 1: Paxalisib - Key Drug Information
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/01/10 | Phase 2 | Recruiting | |||
2021/08/18 | Phase 2 | Recruiting | |||
2021/05/28 | Phase 2 | Recruiting | Lakshmi Nayak, MD | ||
2019/12/10 | Phase 1 | Active, not recruiting | |||
2019/06/21 | Phase 2 | Recruiting | |||
2019/05/31 | Phase 2 | Recruiting | Global Coalition for Adaptive Research | ||
2018/12/05 | Phase 2 | Active, not recruiting | |||
2018/10/04 | Phase 1 | Completed | |||
2018/05/11 | Phase 2 | Completed | |||
2012/03/08 | 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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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