COMPANY

Abeona Therapeutics

HQ: Cleveland, OH source · abeonatherapeutics.com ↗

FDA-approved therapeutic company Clinical Phase 3

Abeona Therapeutics Inc is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. From company website Source · Oct 12, 2026

Keywords: gene therapy Recessive Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa Diabetic Foot Ulcers Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica Mucopolysaccharidosis III-B Mucopolysaccharidosis Type 3 B Onychomycosis EB-101 MSI-78 Prademagene Zamikeracel EB-101 Surgical application of RDEB wounds LZRSE-Col7A1 Engineered Autologous Epidermal Sheets ABO-101 rAAV9.CMV.hNAGLU

Location: Cleveland, OH · source · Oct 14, 2026

Profile checked Oct 10, 2026

11Trials (company is sponsor)1FDA records (2 yrs)

Timeline

2026-11 Trial start 4: Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds source ↗
Jul 25, 2025 Trial start —: A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting source ↗
Apr 28, 2025 FDA FDA New drug/biologic (novel): zevaskyn (prademagene zamikeracel) — BLA125807, Apr 28, 2025. Applicant at approval: Abeona Therapeutics, Inc. source ↗
Apr 2, 2023 Trial start 3: A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients source ↗
Feb 9, 2021 Trial start —: A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB source ↗
Oct 28, 2020 Trial start —: A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101 source ↗
Jan 10, 2020 Trial start 3: Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) source ↗
Oct 16, 2017 Trial start Phase 1/Phase 2: Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB source ↗
Oct 5, 2010 Trial start Phase 1/Phase 2: Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa source ↗
2006-09 Trial start Phase 2: A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail source ↗
1994-08 Trial start Phase 3: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers source ↗
1994-08 Trial start Phase 3: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers source ↗

Upcoming milestones

2031-11 (ESTIMATED) · 4 · Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds · NCT07717736
2036-02 (ESTIMATED) · · A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB · NCT05708677
2045-04 (ESTIMATED) · · A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting · NCT07700966

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 11

Record	Title	Phase	Status	Start	Primary completion
NCT07717736	Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds	4	Not yet recruiting	2026-11	2031-11 (estimated)
NCT05708677	A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB	Not listed	Enrolling by invitation	Feb 9, 2021	2036-02 (estimated)
NCT07700966	A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting	Not listed	Recruiting	Jul 25, 2025	2045-04 (estimated)
NCT05725018	A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients	3	Active, not recruiting	Apr 2, 2023	Sep 30, 2025 (estimated)
NCT01263379	Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa	Phase 1/Phase 2	Completed	Oct 5, 2010	Mar 9, 2022 (actual)
NCT04227106	Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)	3	Completed	Jan 10, 2020	Oct 18, 2022 (actual)
NCT04655911	A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101	Not listed	Terminated	Oct 28, 2020	Apr 7, 2022 (actual)
NCT03315182	Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB	Phase 1/Phase 2	Terminated	Oct 16, 2017	Apr 7, 2022 (actual)
NCT00385502	A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail	Phase 2	Completed	2006-09	2008-06 (actual)
NCT00563433	MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers	Phase 3	Completed	1994-08	1996-07 (actual)
NCT00563394	MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers	Phase 3	Completed	1994-08	1996-07 (actual)

FDA records (last 2 years)

Apr 28, 2025 FDA New drug/biologic (novel): zevaskyn (prademagene zamikeracel) — BLA125807, Apr 28, 2025. Applicant at approval: Abeona Therapeutics, Inc. source ↗

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