Xvie (amniotic fluid injectable)
Xvie (amniotic fluid injectable) is in Phase 1/2 for androgenetic alopecia, developed by Xtressé.
Processed donor amniotic fluid injected into the scalp, from a company that already sells a topical version through clinics.
- Developed by
- Xtressé
- Current phase
- Phase 1/2
- Mechanism
- Growth factor
- Indications
- Androgenetic alopecia
- Also known as
- Xvie, XVIE, decellularized allogeneic human amniotic fluid
- Last public activity
- August 2026
- Copy last reviewed
- September 2026
- Record confidence
- Medium
A combined safety and early-efficacy study.
Delivers growth factors - proteins that tell follicle cells to divide and grow.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
How it is meant to work
Decellularised human amniotic fluid carrying growth factors, extracellular vesicles and hyaluronic acid, injected intradermally. The company's claim is that the mix stimulates follicle activity; no target is named. HST-001, a growth-factor cocktail from cultured fibroblasts, is the closest precedent in this register, and it failed its placebo-controlled endpoint.
Why it matters
Unusual for arriving from the clinic side: Xtressé sells a topical concentrate through licensed providers and a hair-growth supplement, and in March 2026 announced that the FDA had accepted an IND for an injectable form in androgenetic alopecia. The registered Phase 1/2 is placebo-controlled, 30 participants, two injection sessions 90 days apart and six months of follow-up, planned to start in December 2026. The only study of the product as applied today is an open-label pilot of Xvie delivered by microneedling in 15 women with thinning hair, enrolling by invitation since September 2025 with nothing posted; the topical sold now has no controlled trial behind it.
Development history
No phase changes recorded yet.
Registered trials
Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.
XVIE to Treat Androgenetic Alopecia (AGA)
Restore Biologics Holdings, Inc. dba Xtressé · n=30 · December 2026
Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
Restore Biologics Holdings, Inc. dba Xtressé · n=15 · September 2025
Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.
Sources
- XVIE to Treat Androgenetic Alopecia (AGA) — ClinicalTrials.gov
- Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair — ClinicalTrials.gov
- Xtressé announces FDA IND acceptance for Xvie, an extracellular vesicle injectable therapy for androgenetic alopecia — Company release, March 2026
Related programmes
Other programmes in the register with the same mechanism: Growth factor.
Cite this page
Hair Pipeline, "Xvie (amniotic fluid injectable) — development record", hairpipeline.com/pipeline/xvie