Multiple clinical trials are evaluating therapeutic interventions across diverse conditions, including local anesthesia, mild cognitive impairment, Alzheimer's disease, metachromatic leukodystrophy, and Canavan disease. Spanning early Phase 1, Phase 1/2, and Phase 3 evaluations, alongside non-applicable phase designations, these studies maintain recruiting, active but not recruiting, and not yet recruiting statuses. They are spearheaded by academic and industry sponsors, including Radboud University Medical Center, Oregon Health and Science University with the Alzheimer's Association, Orchard Therapeutics, Ospedale San Raffaele, and Aspa Therapeutics.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06205680 | Not yet recruiting | Anesthesia Local |
Radboud University Medical Center |
2024-03-01 | Not Applicable |
| NCT05591027 | Recruiting | Mild Cognitive Impairment|Alzheimer''s Disease |
Oregon Health and Science University|Alzheimer''s Association |
2022-12-01 | Phase 1 |
| NCT04283227 | Active not recruiting | Lysosomal Storage Diseases|Metachromatic Leukodystrophy |
Orchard Therapeutics|Ospedale San Raffaele |
2022-01-17 | Phase 3 |
| NCT04998396 | Recruiting | Canavan Disease |
Aspa Therapeutics |
2021-09-08 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- 1-Naphthaleneacetic acid Solubility in DMSO
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- 1-Naphthaleneacetic acid Chemical Structure (2D and 3D)
- 1-Naphthaleneacetic acid SDS|MSDS