Overview
Guanfacine, or BS 100-141, is a selective alpha-A2 adrenergic receptor agonist initially indicated for the treatment of hypertension but is now indicated as an extended release tablet for the treatment of ADHD. Guanfacine was first described in the literature in 1974. Guanfacine was granted FDA approval on 27 October 1986.
Indication
Guanfacine is indicated alone or as an adjunct with stimulants to treat ADHD.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Gilles de la Tourette's Syndrome
- Hypertension
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/15 | Phase 1 | Not yet recruiting | |||
2024/10/08 | Phase 2 | Not yet recruiting | |||
2024/05/10 | Phase 2 | Not yet recruiting | |||
2023/09/18 | Phase 2 | Recruiting | Rachel G. Greenberg, MD, MB, MHS | ||
2023/07/24 | Phase 2 | Recruiting | Orygen | ||
2022/12/20 | Phase 4 | Completed | |||
2021/02/08 | Phase 2 | Active, not recruiting | |||
2020/10/08 | Phase 3 | Completed | |||
2019/12/13 | Phase 2 | Recruiting | |||
2019/10/02 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-1801 | ORAL | 4 mg in 1 1 | 12/7/2023 | |
| Precision Dose, Inc. | 68094-065 | ORAL | 1 mg in 1 1 | 1/9/2023 | |
| TWi Pharmaceuticals, Inc. | 24979-538 | ORAL | 4 mg in 1 1 | 6/12/2017 | |
| Upsher-Smith Laboratories, LLC | 24979-538 | ORAL | 4 mg in 1 1 | 6/12/2017 | |
| Actavis Pharma, Inc. | 0228-2850 | ORAL | 1 mg in 1 1 | 11/29/2022 | |
| XIROMED, LLC | 70700-302 | ORAL | 2 mg in 1 1 | 2/26/2023 | |
| Bryant Ranch Prepack | 72162-1799 | ORAL | 2 mg in 1 1 | 9/16/2021 | |
| Bryant Ranch Prepack | 72162-2030 | ORAL | 4 mg in 1 1 | 6/12/2023 | |
| Takeda Pharmaceuticals America, Inc. | 54092-513 | ORAL | 1 mg in 1 1 | 8/1/2020 | |
| Physicians Total Care, Inc. | 54868-6447 | ORAL | 1 mg in 1 1 | 4/15/2015 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/17/2015 |
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 |
|---|---|---|---|---|---|
| INTUNIV guanfacine (as hydrochloride) 3 mg modified release tablet blister pack | 275314 | Medicine | A | 8/22/2017 | |
| Guanfacine 1 TAKEDA, guanfacine (as hydrochloride) 1 mg modified release tablet blister pack | 395368 | Medicine | A | 12/2/2022 | |
| Guanfacine 3 TAKEDA, guanfacine (as hydrochloride) 3 mg modified release tablet blister pack | 395373 | Medicine | A | 12/2/2022 | |
| INTUNIV guanfacine (as hydrochloride) 4 mg modified release tablet blister pack | 275315 | Medicine | A | 8/22/2017 | |
| INTUNIV guanfacine (as hydrochloride) 1 mg modified release tablet blister pack | 275278 | Medicine | A | 8/22/2017 | |
| Guanfacine 4 TAKEDA, guanfacine (as hydrochloride) 4 mg modified release tablet blister pack | 395374 | Medicine | A | 12/2/2022 | |
| Guanfacine 2 TAKEDA, guanfacine (as hydrochloride) 2 mg modified release tablet blister pack | 395369 | Medicine | A | 12/2/2022 | |
| INTUNIV guanfacine (as hydrochloride) 2 mg modified release tablet blister pack | 275313 | Medicine | A | 8/22/2017 |
Help Us Improve
Your feedback helps us provide better drug information and insights.