Drugs / FS2
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04186273 | Dec 2019 → Feb 2021 | keloid, keloid formation | University of British Columbia | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06807021 | May → Oct 2026 expected | — | Birch BioMed Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Birch BioMed Inc | Regulatory BirchBioMed Receives Health Canada Approval for Topical Cream (NPN 80147114) birchbiomed.com ↗
BirchBioMed Inc. today announced that following a comprehensive review of the product’s safety, quality, and efficacy by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD), its FS2 (KynA) topical cream has been granted regulatory approval as a natural health product (no prescription required) for distribution in Canada as a treatment for scars, even severe ones like mature keloids. |
| 2025-12-02 | Birch BioMed Inc | Regulatory U.S. FDA Grants BirchBioMed Orphan Drug Designation for FS2 in the Treatment of Idiopathic Pulmonary Fibrosis birchbiomed.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis (IPF). |
| 2024-10-30 | Birch BioMed Inc | Regulatory BirchBioMed Receives Health Canada Green Light to Start the Last Stage of its Groundbreaking Clinical Program of FS2 to Minimize Scarring from Burns birchbiomed.com ↗
BirchBioMed, a leading biopharmaceutical company expert in the development of products for scarring and other fibrosis-related disorders, announced the authorization from Health Canada to conduct its Phase II/III randomized clinical trial of a naturally based compound, FS2, at multiple centres of expertise throughout Canada. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Birch BioMed Inc | BirchBioMed Receives Health Canada Approval for Topical Cream (NPN 80147114) birchbiomed.com ↗ |
| 2025-12-02 | Birch BioMed Inc | U.S. FDA Grants BirchBioMed Orphan Drug Designation for FS2 in the Treatment of Idiopathic Pulmonary Fibrosis birchbiomed.com ↗ |
| 2024-10-30 | Birch BioMed Inc | BirchBioMed Receives Health Canada Green Light to Start the Last Stage of its Groundbreaking Clinical Program of FS2 to Minimize Scarring from Burns birchbiomed.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FS2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04186273 ↗ |
| Known as | kynurenic acid | “The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery.” NCT06807021 ↗ |
| Route | Topical | “topically applied to designated treatment sites once per day” NCT04186273 ↗ |