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ON101 Cream
ON101 Cream is a Topical wound healing agent Small molecule drug developed by Oneness Biotech Co., Ltd.. It is currently FDA-approved for Chronic diabetic foot ulcers, Pressure ulcers / decubitus ulcers. Also known as: WH-1, Fespixon.
ON101 Cream is a topical formulation that promotes wound healing and tissue repair through growth factor signaling and anti-inflammatory mechanisms.
ON101 Cream is a topical formulation that promotes wound healing and tissue repair through enhanced growth factor signaling and cellular regeneration. Used for Chronic wounds and diabetic foot ulcers.
At a glance
| Generic name | ON101 Cream |
|---|---|
| Also known as | WH-1, Fespixon |
| Sponsor | Oneness Biotech Co., Ltd. |
| Drug class | Topical wound healing agent |
| Target | Fibroblast growth factor receptor (FGFR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Wound Care |
| Phase | FDA-approved |
Mechanism of action
ON101 is a proprietary topical cream containing recombinant human basic fibroblast growth factor (bFGF) that stimulates angiogenesis, fibroblast proliferation, and extracellular matrix deposition. It is designed to accelerate the healing process in chronic wounds by promoting granulation tissue formation and re-epithelialization through growth factor-mediated cellular signaling.
Approved indications
- Chronic diabetic foot ulcers
- Pressure ulcers / decubitus ulcers
Common side effects
- Local irritation or erythema at application site
- Infection risk at wound site
- Allergic reaction to formulation components
Key clinical trials
- Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer
- Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (PHASE3)
- A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers. (PHASE4)
- Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B) (PHASE4)
- Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound (PHASE4)
- Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients (PHASE4)
- A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs. (NA)
- Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ON101 Cream CI brief — competitive landscape report
- ON101 Cream updates RSS · CI watch RSS
- Oneness Biotech Co., Ltd. portfolio CI
Frequently asked questions about ON101 Cream
What is ON101 Cream?
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What does ON101 Cream target?
Related
- Drug class: All Topical wound healing agent drugs
- Target: All drugs targeting Fibroblast growth factor receptor (FGFR)
- Manufacturer: Oneness Biotech Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Dermatology / Wound Care
- Indication: Drugs for Chronic diabetic foot ulcers
- Indication: Drugs for Pressure ulcers / decubitus ulcers
- Also known as: WH-1, Fespixon
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing