This section highlights FDA-related milestones and regulatory updates for drugs developed by FibroBiologics (FBLG).
Over the past two years, FibroBiologics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CYWC628, CYPS317, and Human. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CYWC628 FDA Regulatory Timeline and Events
CYWC628 is a drug developed by FibroBiologics for the following indication: Treatment of Refractory Diabetic Foot Ulcers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CYWC628
- Announced Date:
- May 4, 2026
- Indication:
- Treatment of Refractory Diabetic Foot Ulcers
Announcement
FibroBiologics, Inc. announced the release of the first batch of its CYWC628 drug product to support its Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).
AI Summary
FibroBiologics, Inc. announced the release of the first batch of its CYWC628 drug product to support a Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs). The product was manufactured under the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) and successfully passed all required safety and quality tests, clearing it for clinical use.
CYWC628 is an investigational, fibroblast-based therapy aimed at treating DFUs, a chronic wound problem that affects millions and often lacks long-term effective options. The upcoming Phase 1/2 trial will evaluate the drug’s safety, tolerability, and early signs of effectiveness in people with DFUs. Releasing this first cGMP batch is a key step toward starting and supporting those clinical evaluations.
Read Announcement- Drug:
- CYWC628
- Announced Date:
- March 31, 2026
- Indication:
- Treatment of Refractory Diabetic Foot Ulcers
Announcement
FibroBiologics, Inc., announced the successful completion of manufacturing of the first batch of FibroBiologics' proprietary CYWC628 drug product that will support upcoming first-in-human clinical trials. Manufactured in accordance with Food and Drug Administration's (FDA's) Good Manufacturing Practices (CGMP), the drug product will be released after it successfully passes all required safety and quality testing.
AI Summary
FibroBiologics, Inc. announced it completed manufacture of the first batch of its proprietary CYWC628 drug product to support upcoming first-in-human clinical trials. The company said the batch was produced in accordance with the U.S. Food and Drug Administration’s current Good Manufacturing Practices (CGMP). The drug product will only be released after it successfully passes all required safety and quality testing, a step designed to confirm potency, purity, sterility, and other regulatory standards before it can be used in human studies.
CYWC628 is a fibroblast-based therapy aimed at treating diabetic foot ulcers, a serious condition that affects millions and currently lacks proven long-term solutions. This manufacturing milestone moves the program closer to clinical testing, where safety and early efficacy will be evaluated in patients.
Read Announcement- Drug:
- CYWC628
- Announced Date:
- March 5, 2026
- Indication:
- Treatment of Refractory Diabetic Foot Ulcers
Announcement
FibroBiologics, Inc. announced that onboarding of the clinical sites has been completed for its Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers (DFUs).
AI Summary
FibroBiologics announced that onboarding of clinical sites has been completed for its Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers. The trial will assess wound healing outcomes, durability of response, and safety through regular clinical observation, testing, and imaging. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to evaluate primary safety and efficacy endpoints, the company said.
CYWC628 is an investigational topically administered allogeneic fibroblast cell therapy. Preclinical data suggest it may significantly accelerate wound healing compared to current treatments. The planned study is a prospective, multicenter, open-label trial of up to 12 weeks. Participants will receive either standard of care plus a low or high dose of CYWC628, or standard of care only. The trial will evaluate tolerability, safety, and effectiveness in patients with refractory diabetic foot ulcers.
Read Announcement- Drug:
- CYWC628
- Announced Date:
- November 20, 2025
- Indication:
- Treatment of Refractory Diabetic Foot Ulcers
Announcement
FibroBiologics, Inc. announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers (DFU).
AI Summary
FibroBiologics announced it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 trial of CYWC628 to treat refractory diabetic foot ulcers. With the HREC approvals and a completed Therapeutics Goods Administration (TGA) filing, the company says it has secured the regulatory clearances needed to begin the study. The trial will enroll 120 patients at 10 sites across Australia.
Southern Star Research, a full-service Australian CRO, will manage the study. The prospective, multicenter, randomized trial will test topical allogeneic fibroblast therapy given with standard of care (SoC) at low or high dose, compared with SoC alone, for up to 12 weeks. Researchers will track wound healing, response rates, and safety using clinical exams and imaging. An interim analysis is planned after a set number of participants complete six weeks to evaluate primary safety and efficacy endpoints.
The study aims to confirm safety and provide clinical data supporting CYWC628 as a new fibroblast-based option for chronic wound care.
Read Announcement
CYPS317 FDA Regulatory Events
CYPS317 is a drug developed by FibroBiologics for the following indication: Patients with Psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CYPS317
- Announced Date:
- December 31, 2025
- Indication:
- Patients with Psoriasis
Announcement
FibroBiologics, Inc. announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis.
AI Summary
FibroBiologics, Inc. announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317, an investigational allogeneic fibroblast spheroid‑based therapy for moderate to severe psoriasis. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data intended to support CYPS317’s mechanism of action, durability of effect, and safety profile. FibroBiologics plans to advance toward first‑in‑human studies following FDA review of the filing.
In preclinical models, a single dose of CYPS317 matched or exceeded the effects of multiple doses of anti‑IL‑23 monoclonal antibodies and produced notable reductions in disease recurrence, suggesting durable immunomodulatory activity. The company views this filing as a key step in developing a potential new treatment option aimed at more durable control of psoriasis symptoms. FibroBiologics is a clinical‑stage biotech developing fibroblast‑based therapies for chronic diseases.
Read Announcement
Human dermal fibroblast FDA Regulatory Events
Human dermal fibroblast is a drug developed by FibroBiologics for the following indication: in Chronic-Relapse Psoriasis Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Human dermal fibroblast
- Announced Date:
- September 11, 2025
- Indication:
- in Chronic-Relapse Psoriasis Treatment
Announcement
FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.
AI Summary
FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program showing human dermal fibroblast (HDF) spheroids could treat chronic-relapse psoriasis. In an acute psoriasis model, a single HDF spheroid dose matched the effect of multiple injections of an anti–IL-23 antibody. In a chronic-relapse model, that same single treatment significantly reduced disease recurrence. These findings suggest HDF spheroids may provide a durable response with fewer administrations compared to current biologics.
FibroBiologics plans to expand this work by testing repeated dosing, analyzing systemic and local cytokine profiles, and conducting histopathology of skin lesions to understand how HDF spheroids work. The company believes these IND-enabling results mark a pivotal step toward a scalable, durable therapy for chronic inflammatory diseases. Ultimately, it aims to develop a single HDF spheroid treatment that offers long-term protection against psoriasis relapse, shifting the treatment paradigm for millions of patients.
Read Announcement
