Overview
Osteoarthritis (OA) is a progressive and degenerative joint disease marked by loss of cartilage, bone changes, and synovial membrane inflammation. Treatment with chondroprotective drugs, such as glucosamine sulfate may offer additional benefits to nonsteroidal anti-inflammatory drugs treating the painful symptoms of OA. Glucosamine is commonly used over the counter as a treatment for arthritic joint pain, although its acceptance as a medical therapy varies due to contradictory and findings with unclear clinical significance during clinical trials. It is currently not approved as a prescription product by the FDA, but is widely available over the counter.
Background
Osteoarthritis (OA) is a progressive and degenerative joint disease marked by loss of cartilage, bone changes, and synovial membrane inflammation. Treatment with chondroprotective drugs, such as glucosamine sulfate may offer additional benefits to nonsteroidal anti-inflammatory drugs treating the painful symptoms of OA. Glucosamine is commonly used over the counter as a treatment for arthritic joint pain, although its acceptance as a medical therapy varies due to contradictory and findings with unclear clinical significance during clinical trials. It is currently not approved as a prescription product by the FDA, but is widely available over the counter.
Indication
Glucosamine is generally used over the counter in the symptomatic treatment of osteoarthritis and joint pain, frequently combined with chondroitin sulfate and/or ibuprofen.
Associated Conditions
- Back pain
- Joint Pain
- Osteoarthritis (OA)
- Osteoarthritis of the Knee
- Articular inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/11 | Phase 2 | Completed | |||
2022/02/14 | N/A | Completed | |||
2022/01/28 | Not Applicable | Recruiting | |||
2019/05/03 | Phase 3 | Withdrawn | Eurofarma Laboratorios S.A. | ||
2019/04/11 | N/A | Completed | |||
2018/11/16 | Phase 4 | Completed | |||
2018/10/23 | Phase 2 | Completed | |||
2017/06/28 | N/A | UNKNOWN | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2016/08/08 | Phase 4 | Completed | |||
2016/07/13 | Phase 3 | Completed | Eurofarma Laboratorios S.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Home Aide Diagnostics, Inc. | 69379-285 | TOPICAL | 5 g in 100 g | 3/9/2015 |
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 |
|---|---|---|---|---|---|
| Glucosamine Sulfate Powder | H20150347 | 化学药品 | 散剂 | 6/19/2020 | |
| Glucosamine Sulfate Powder | 国药准字HJ20150347 | 化学药品 | 散剂 | 4/29/2025 | |
| Glucosamine Sulfate Effervescent Tablets | 国药准字H20090310 | 化学药品 | 片剂 | 7/29/2019 | |
| Glucosamine Sulfate Tablets | 国药准字H20041317 | 化学药品 | 片剂 | 2/23/2020 | |
| Glucosamine Sulfate Granules | 国药准字H20090077 | 化学药品 | 颗粒剂 | 7/13/2023 | |
| Glucosamine Potassium Sulfate Tablets | 国药准字H20051759 | 化学药品 | 片剂 | 8/5/2020 | |
| Glucosamine Hydrochloride Granules | 国药准字H20140004 | 化学药品 | 颗粒剂 | 7/6/2023 | |
| Glucosamine Hydrochloride Granules | 国药准字H20090094 | 化学药品 | 颗粒剂 | 8/11/2023 | |
| Glucosamine Hydrochloride Capsules | 国药准字H20173212 | 化学药品 | 胶囊剂 | 2/17/2022 | |
| Glucosamine Hydrochloride Capsules | 国药准字J20140166 | N/A | 胶囊剂 | 10/14/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| GLUCOSAMINE POWDER FOR ORAL SOLUTION 1.5G/SACHET | N/A | N/A | N/A | 3/23/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Quality Health Australia Daily Glucosamine Sulfate 1500mg | 235126 | Pharmacare Laboratories Pty Ltd | Medicine | A | 3/17/2015 |
| Glucosamine HCL 1500mg TAB | 169608 | Medicine | A | 3/5/2010 | |
| Glucosamine Powder Sachet | 157319 | Medicine | A | 11/27/2008 | |
| JointBiotics Glucosamine 1500mg and Chondroitin 100mg | 302975 | Medicine | A | 5/14/2018 | |
| YHL 3 IN 1 FORMULA JOINT MOBILITY | 354030 | Medicine | A | 2/2/2021 | |
| Glucosamine Premium Repair | 315815 | Medicine | A | 3/27/2019 | |
| Austar Joint Care | 444208 | Medicine | A | 3/22/2024 | |
| JoinTQ | 384091 | Medicine | A | 2/16/2022 | |
| BioSource Glucosamine HCl 1500 mg | 331183 | Medicine | A | 3/16/2020 | |
| Thompson's Glucosamine & Chondroitin with Boron | 406330 | Medicine | A | 3/17/2023 |