Epidermolysis Bullosa

9
Pipeline Programs
6
Companies
9
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
5
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Organogenesis
OrganogenesisCANTON, MA
1 program
1
ApligrafPhase 41 trial
Active Trials
NCT01619670TerminatedEst. Jan 2015
Amicus Therapeutics
Amicus TherapeuticsPA - Philadelphia
4 programs
2
2
SD-101-6.0 creamPhase 31 trial
SD-101-6.0 creamPhase 31 trial
SD-101 dermal creamPhase 21 trial
SD-101 dermal creamPhase 21 trial
Active Trials
NCT02090283TerminatedEst. Sep 2018
NCT02014376CompletedEst. Jun 2014
NCT02384460CompletedEst. Jul 2017
+1 more trials
Abeona Therapeutics
Abeona TherapeuticsCLEVELAND, OH
2 programs
2
EB-101Phase 31 trial
EB-101 Surgical application of RDEB woundsPhase 31 trial
Active Trials
NCT04227106CompletedEst. Oct 2022
NCT05725018Active Not RecruitingEst. Sep 2025
AP
Amryt PharmaUK - London
1 program
1
Oleogel-S10Phase 31 trial
Active Trials
NCT03068780Completed223Est. May 2022
Takeda
TakedaTOKYO, Japan
1 program
1
CX501Phase 21 trial
Active Trials
NCT00987142Completed12Est. May 2010

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OrganogenesisApligraf
Abeona TherapeuticsEB-101 Surgical application of RDEB wounds
Abeona TherapeuticsEB-101
Amryt PharmaOleogel-S10
Amicus TherapeuticsSD-101-6.0 cream
Amicus TherapeuticsSD-101-6.0 cream
Amicus TherapeuticsSD-101 dermal cream
Amicus TherapeuticsSD-101 dermal cream
TakedaCX501

Clinical Trials (9)

Total enrollment: 235 patients across 9 trials

NCT01619670OrganogenesisApligraf

A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

Start: Jun 2012Est. completion: Jan 2015
Phase 4Terminated
NCT05725018Abeona TherapeuticsEB-101 Surgical application of RDEB wounds

A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

Start: Apr 2023Est. completion: Sep 2025
Phase 3Active Not Recruiting
NCT04227106Abeona TherapeuticsEB-101

Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Start: Jan 2020Est. completion: Oct 2022
Phase 3Completed
NCT03068780Amryt PharmaOleogel-S10

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Start: Mar 2017Est. completion: May 2022223 patients
Phase 3Completed
NCT02670330Amicus TherapeuticsSD-101-6.0 cream

Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

Start: Jun 2015Est. completion: Sep 2018
Phase 3Terminated
NCT02384460Amicus TherapeuticsSD-101-6.0 cream

ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

Start: Mar 2015Est. completion: Jul 2017
Phase 3Completed
NCT02090283Amicus TherapeuticsSD-101 dermal cream

Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

Start: Mar 2014Est. completion: Sep 2018
Phase 2Terminated
NCT02014376Amicus TherapeuticsSD-101 dermal cream

Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

Start: Jan 2014Est. completion: Jun 2014
Phase 2Completed
NCT00987142TakedaCX501

Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa

Start: Dec 2006Est. completion: May 201012 patients
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
6 companies competing in this space