Last updated April 29, 2026
At-a-glance table
| Drug | Mechanism (brief) | Formulation | Efficacy1 | Key adverse effects | Status (Oct 2025) | Sources |
|---|---|---|---|---|---|---|
| VDPHL01 | Extended-release oral minoxidil (K⁺ channel opener); gel-matrix avoids cardiac peak concentrations | Oral tablet 8.5 mg QD or BID (investigational) | +30.3–33.0 hairs/cm² vs +7.3 placebo @6 mo; 79–86% patient-reported improvement (Study ‘302’, Apr 2026) | TEAE rates similar to placebo; no cardiac AESIs; no treatment-related SAEs | Phase 2/3 Study ‘302’ ✓ positive (Apr 2026); Study ‘304’ results pending H2 2026; NDA filing planned early 2027 | Business Wire Apr 2026 |
| Finasteride (Propecia) |
5-α-reductase type II inhibitor | Oral 1 mg daily | ↑hair count ≈15 % vs baseline @12 mo | ↓ libido, ED, mood changes (1-3 %) | FDA-approved 1997 | FDA label; J Invest Derm 2012 |
| Dutasteride (Avodart, off-label) |
5-α-reductase I/II inhibitor | Oral 0.5 mg daily | ↑hair count ≈18-20 % @12 mo | Higher sexual AEs vs finasteride | Approved for BPH; AGA trials Phase 3 (Korea) | Drugs.com; J Derm Sci 2020 |
| Minoxidil (topical) | Vasodilator; K+ channel opener | 5 % foam / solution BID | ↑hair count ≈10-12 % @48 wk | Scalp irritation, shedding, hypertrichosis | FDA-approved 1988 | FDA label; Cochrane 2019 |
| Minoxidil (oral, low-dose, off-label) | Systemic vasodilator; immediate-release — causes concentration spikes | 1–5 mg daily (off-label; no standardised dose) | ↑hair count ≈15% @24 wk (small pilots); no large RCT data | Edema, tachycardia, hypertrichosis (29–87% depending on dose), pericardial effusion (rare) | Not FDA-approved for AGA; used off-label. VDPHL01’s extended-release formulation was designed specifically to address these safety limitations. | JAAD 2022; NCT05513045 |
| Clascoterone (Breezula) |
Topical androgen-receptor antagonist | 1 % solution BID | ↑hair density ≈14 % @12 mo | Mild erythema; no systemic AEs | Phase 3 completed; EMA filing expected | Cosmo Pharma PR 2023; JAMA Derm 2022 |
| Pyrilutamide (KX-826) |
Topical androgen-receptor antagonist | 0.5 % solution BID | ↑hair count ≈13 % @24 wk (Phase 2) | Transient itching; low systemic levels | Phase 3 recruiting (China, US) | Kintor Pharma PR 2025; NCT05604110 |
1Efficacy values are mean non-vellus hair count change vs baseline in representative trials.
Note on VDPHL01 vs off-label oral minoxidil: Both are oral minoxidil, but the formulation differs fundamentally. Standard immediate-release tablets produce high peak plasma concentrations linked to cardiovascular side effects. VDPHL01’s proprietary gel-matrix delivers steady, long-lasting release — avoiding those peaks while extending time above the hair-growth threshold. Study ‘302’ is the first Phase 3 RCT to demonstrate oral minoxidil efficacy and safety at scale.
Which option suits whom?
- Younger patients, fertility concerns → favour non-hormonal or topical options (minoxidil, clascoterone, future VDPHL01).
- Rapid stabilisation needed → oral finasteride or dutasteride (with sexual-AE counselling).
- Multi-modal responders → combination of topical minoxidil + systemic 5-ARI; future studies needed for VDPHL01 add-on.
- Intolerance to systemic therapy → topical AR antagonists; PRP / hair transplantation.
Detailed mechanism notes are on each drug’s dedicated page (no duplication here).
Sources
- FDA Drug Label: Finasteride 1 mg (revised 2023) [accessed 22 Oct 2025]
- Cochrane Review: Interventions for AGA (2019) [accessed 22 Oct 2025]
- JAMA Dermatology 2022;158:1234-1242 — Clascoterone Phase 2b
- ClinicalTrials.gov: NCT06724614; NCT05604110; NCT05513045 (accessed 22 Oct 2025)