Overview
A potent direct-acting peripheral vasodilator (vasodilator agents) that reduces peripheral resistance and produces a fall in blood pressure.
Indication
For the treatment of severe hypertension and in the topical treatment (regrowth) of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia.
Associated Conditions
- Androgenetic Alopecia (AGA)
- Severe, symptomatic Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Early Phase 1 | Recruiting | Shanghai Zhongshan Hospital | ||
2025/06/08 | Phase 2 | Active, not recruiting | PDFE Pharma Innovations FZCO | ||
2025/04/11 | Phase 3 | Not yet recruiting | Samson Clinical Operations Pty Ltd | ||
2025/02/13 | Phase 2 | Not yet recruiting | |||
2024/07/30 | Early Phase 1 | Completed | |||
2024/07/15 | Phase 3 | Not yet recruiting | |||
2024/07/03 | Phase 3 | Withdrawn | |||
2024/03/27 | Phase 1 | Recruiting | |||
2024/01/23 | Not Applicable | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/01/23 | Not Applicable | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-1490 | ORAL | 10 mg in 1 1 | 8/30/2023 | |
| Shenzhen Joyuflsh Technology Co.,Ltd. | 83766-106 | TOPICAL | 5 g in 100 mL | 5/26/2025 | |
| Bryant Ranch Prepack | 63629-2231 | ORAL | 10 mg in 1 1 | 12/4/2018 | |
| Praxis, LLC | 59368-334 | TOPICAL | 5 g in 100 mL | 1/1/2023 | |
| Bryant Ranch Prepack | 63629-9299 | ORAL | 10 mg in 1 1 | 12/4/2018 | |
| AvKARE | 42291-618 | ORAL | 2.5 mg in 1 1 | 10/26/2023 | |
| Roman Health Ventures Inc. | 72484-097 | TOPICAL | 5 g in 100 mL | 1/30/2025 | |
| CVS Pharmacy | 69842-598 | TOPICAL | 5 g in 100 mL | 5/22/2025 | |
| Bryant Ranch Prepack | 63629-2232 | ORAL | 2.5 mg in 1 1 | 12/4/2018 | |
| Proficient Rx LP | 71205-757 | ORAL | 2.5 mg in 1 1 | 2/1/2023 |
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 |
|---|---|---|---|---|---|
| GROWELL SCALP LOTION 2% w/v | SIN10301P | LOTION | 2% w/v | 10/23/1998 | |
| GROWELL SCALP LOTION 3% w/v | SIN09083P | LOTION | 3% w/v | 12/18/1996 | |
| REGAINE Extra Strength (5%) | SIN08213P | SOLUTION | 5.07% w/w (5% w/v) | 6/19/1995 | |
| VELLO-5 TOPICAL SOLUTION 5% W/V | SIN16570P | SOLUTION | 50.00mg/ml | 8/12/2022 | |
| MINOXIDIL LOTION 3% w/v | SIN04690P | LOTION | 3% w/v | 6/13/1990 | |
| REGAINE Regular Strength (2%) | SIN04399P | SOLUTION | 20 mg/ml | 5/3/1990 | |
| GROWELL SCALP LOTION 5% w/v | SIN09084P | LOTION | 5% w/v | 12/18/1996 | |
| REGRO LOTION 5% | SIN08987P | LOTION | 5% w/v | 11/2/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Minoxidil Spray | 国药准字H20110149 | 化学药品 | 喷雾剂 | 10/12/2021 | |
| Minoxidil Spray | 国药准字H20110148 | 化学药品 | 喷雾剂 | 10/12/2021 | |
| Minoxidil Gel | 国药准字H20050314 | 化学药品 | 凝胶剂 | 4/24/2020 | |
| Minoxidil Tincture | 国药准字H20103166 | 化学药品 | 酊剂 | 2/12/2020 | |
| Minoxidil Tincture | 国药准字H20010714 | 化学药品 | 酊剂 | 9/5/2024 | |
| Minoxidil Foam | 国药准字H20234731 | 化学药品 | 泡沫剂 | 3/6/2024 | |
| Minoxidil Liniment | 国药准字H20253431 | 化学药品 | 搽剂 | 2/20/2025 | |
| Minoxidil Liniment | 国药准字H20253430 | 化学药品 | 搽剂 | 2/20/2025 | |
| Minoxidil Liniment | 国药准字H20249808 | 化学药品 | 搽剂 | 12/25/2024 | |
| Minoxidil Liniment | 国药准字H20249221 | 化学药品 | 搽剂 | 10/29/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| REGAINE FOR WOMEN TOPICAL FOAM 5%W/W | N/A | N/A | N/A | 5/15/2017 | |
| MYDEL SOLUTION 5% W/V | N/A | N/A | N/A | 9/6/2018 | |
| REGAINE FOR MEN TOPICAL FOAM 5%W/W | N/A | N/A | N/A | 9/29/2015 | |
| REGAINE EXTRA STRENGTH FOR MEN TOPICAL SOLN 5% | N/A | N/A | N/A | 4/30/2004 |
TGA Drug Approvals
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