Beremagene geperpavec



Beremagene geperpavec is gene therapy used to treat wounds associated with dystrophic epidermolysis bullosa.

Brand Names
Generic Name
Beremagene geperpavec
DrugBank Accession Number

Beremagene geperpavec is a live, replication-defective herpes simplex virus type 1 (HSV-1)-based vector therapy. Developed by Krystal Biotech, it was first approved by the FDA on May 19, 2023, for the treatment of wounds associated with dystrophic epidermolysis bullosa (DEB).5 DEB is caused by mutations in the COL7A1 gene that encodes collagen VII (COL7), a major component of the anchoring fibrils for dermal–epidermal cohesion.1 Beremagene geperpavec is genetically modified to deliver COL7A1, thereby restoring the levels of the COL7 protein.4

Biologic Classification
Gene Therapies
Other gene therapies
  • B-VEC
  • Bercolagene telserpavec
  • Dna (recombinant herpes simplex virus type 1 strain kos plasmid vector kb103 human collagen col7a1-specifying)
External IDs
  • KB-103
  • KB103



Beremagene geperpavec is indicated for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.4

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Associated Conditions
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Beremagene geperpavec is a gene therapy that restores the deficient levels of human type VII collagen (COL7) protein.4 In RDEB mice and human RDEB xenografts, beremagene geperpavec restored C7 expression in keratinocytes and fibroblasts.1 In a trial comprising patients with dystrophic epidermolysis bullosa, the topical administration of beremagene geperpavec was associated with greater wound healing at three and six months compared to placebo.3

Mechanism of action

Collagen VII (C7, COL7), encoded by the COL7A1 gene, is an anchoring fibril component that holds the epidermis and dermis together to maintain skin integrity.1,2 COL7 is synthesized by epidermal keratinocytes and dermal fibroblasts.2 Dystrophic epidermolysis bullosa (DEB) is an inherited disorder caused by COL7A1 gene mutations, leading to reduced or deficient levels of biologically active and functional COL7. Deficient levels of COL7 result in no functional anchoring fibrils and impaired dermal-epidermal adhesion.1,2 DEB is associated with blistering, wounding, and scarring of the skin and other organs starting at birth.1,4

Beremagene geperpavec is a herpes simplex virus type 1 (HSV-1)-based vector genetically modified to express COL7. Upon topical application to wounds, beremagene geperpavec enters both keratinocytes and fibroblasts and the vector genome is deposited in the nucleus. Once in the nucleus, transcription of the encoded human COL7A1 is initiated to produce and secrete COL7 by the cell in its mature form. COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils.4


There is limited information available regarding the absorption of beremagene geperpavec. In an initial clinical study, viral vector DNA was detected in skin swab samples in all nine treated subjects, with a maximum level ranging from 5.1×104 to 4.1×108 vector genomes.4

Volume of distribution

There is no information available.

Protein binding

There is no information available.


There is no information available.

Route of elimination

There is limited information available. In an initial clinical study involving subjects who received beremagene geperpavec via skin swabs, no viral vector DNA was detected in blood or urine.4


There is no information available.


There is no information available.

Adverse Effects
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There is no information available regarding acute toxicity and overdosage of beremagene geperpavec.

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.


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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
VyjuvekKit; Suspension5000000000 [PFU]/1mLTopicalKrystal Biotech, Inc.2023-05-19Not applicableUS flag


Drug Categories
Not classified
Affected organisms
Not Available

Chemical Identifiers

CAS number


General References
  1. Gurevich I, Agarwal P, Zhang P, Dolorito JA, Oliver S, Liu H, Reitze N, Sarma N, Bagci IS, Sridhar K, Kakarla V, Yenamandra VK, O'Malley M, Prisco M, Tufa SF, Keene DR, South AP, Krishnan SM, Marinkovich MP: In vivo topical gene therapy for recessive dystrophic epidermolysis bullosa: a phase 1 and 2 trial. Nat Med. 2022 Apr;28(4):780-788. doi: 10.1038/s41591-022-01737-y. Epub 2022 Mar 28. [Article]
  2. Shinkuma S: Dystrophic epidermolysis bullosa: a review. Clin Cosmet Investig Dermatol. 2015 May 26;8:275-84. doi: 10.2147/CCID.S54681. eCollection 2015. [Article]
  3. Guide SV, Gonzalez ME, Bagci IS, Agostini B, Chen H, Feeney G, Steimer M, Kapadia B, Sridhar K, Quesada Sanchez L, Gonzalez F, Van Ligten M, Parry TJ, Chitra S, Kammerman LA, Krishnan S, Marinkovich MP: Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa. N Engl J Med. 2022 Dec 15;387(24):2211-2219. doi: 10.1056/NEJMoa2206663. [Article]
  4. FDA Approved Drug Products: VYJUVEK (beremagene geperpavec-svdt) biological suspension mixed with excipient gel for topical application [Link]
  5. BioSpace: Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa [Link]

Clinical Trials

Clinical Trials
3CompletedTreatmentDEB - Dystrophic Epidermolysis Bullosa / Dominant Dystrophic Epidermolysis Bullosa / Dystrophic Epidermolysis Bullosa / Recessive Dystrophic Epidermolysis Bullosa1
3CompletedTreatmentDominant Dystrophic Epidermolysis Bullosa / Dystrophic Epidermolysis Bullosa / Recessive Dystrophic Epidermolysis Bullosa1
1, 2CompletedTreatmentDystrophic Epidermolysis Bullosa1


Not Available
Not Available
Dosage Forms
Kit; suspensionTopical5000000000 [PFU]/1mL
Not Available
Not Available


Not Available
Experimental Properties
Not Available

Drug created at May 26, 2023 19:11 / Updated at June 23, 2023 10:36