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Stem bromelain

Generic Name
Stem bromelain
Brand Names
NexoBrid
Drug Type
Biotech
CAS Number
37189-34-7
Unique Ingredient Identifier
ZLM4P8929R
Background

The primary therapeutic use for which stem bromelain is currently and formally indicated is as a burn wound eschar debridement agent that has been approved by the EMA since 2012 and marketed under the brand name Nexobrid .

Bromelain itself belongs to a category of protein-digesting enzymes that are obtained commercially from the fruit or stem of pineapples . Although both fruit and stem bromelain are prepared differently and contain different enzymatic compositions, the general term bromelain typically refers to stem bromelain . Bromelain is consequently a composite mixture of several different endopeptidases that can facilitate many different reactions with many different substrates. This action allows bromelain to demonstrate a wide range of therapeutic benefits ranging from cardiovascular to anticancer therapy - but the specific mechanisms of action by which it can elicit these effects are currently not properly understood.

Indication

The primary medical purpose for which stem bromelain (SB) is currently indicated for is the removal of eschar in adults with deep partial- and full-thickness thermal burns .

Besides this official indication, however, it is also believed that SB may be used as a treatment for several other purposes as well, including cardiovascular health, osteoarthritis, autoimmunity, blood clotting, diarrhea, cancer, surgery, and debridement - although the specific mechanisms of action for these indications remain to be elucidated .

Associated Therapies
Eschar removal
Clinical Trials
Related News

NexoBrid Shows Superior Results in Phase III Pediatric Burn Treatment Study

• Phase III CIDS trial demonstrates NexoBrid's effectiveness in pediatric burn patients, achieving complete eschar removal in one day compared to six days with standard care. • The enzymatic treatment significantly reduced the need for surgical intervention, with only 8.3% of NexoBrid-treated patients requiring surgical excision versus 64.4% in standard care. • Study results published in Burns journal validate NexoBrid's safety profile and long-term outcomes, supporting its recent pediatric use approval in the U.S., E.U., and Japan.

Mediwound Receives Buy Rating Due to EscharEx's Market Potential

Mediwound has been given a Buy rating by Michael Okunewitch of Maxim Group, driven by the promising market potential of its product EscharEx in chronic wound care, with a price target of $30.00.

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MediWound Initiates Phase III Trial of EscharEx for Venous Leg Ulcers

• MediWound has commenced a Phase III clinical trial (VALUE) to evaluate EscharEx for the treatment of venous leg ulcers (VLUs). • The VALUE trial is a randomized, double-blind, placebo-controlled study across 40 sites in the U.S. and Europe, enrolling 216 patients. • EscharEx has shown promise in Phase II trials, demonstrating effective and rapid debridement of chronic wounds, potentially redefining VLU treatment. • An interim analysis of the VALUE trial is expected in mid-2026, with strategic collaborations in place to ensure consistent wound management.

MediWound Initiates Phase II Trial of EscharEx for Venous Leg Ulcer Treatment

• MediWound has commenced a Phase II clinical trial to assess EscharEx for treating venous leg ulcers, with results expected to support a BLA submission. • The trial is a randomized, multicenter study comparing EscharEx to collagenase ointment (Santyl) and placebo across 45 patients in the U.S. and Europe. • Strategic R&D collaborations with Solventum and Mölnlycke Health Care will ensure consistency in the study through the use of advanced wound care products. • EscharEx, a bioactive debridement therapy, has shown promise in earlier trials and is also being developed for diabetic foot ulcers.

September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases

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FDA Approves NexoBrid for Pediatric Thermal Burn Treatment

• The FDA has approved NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and full-thickness thermal burns. • This approval is based on the Phase 3 CIDS trial and other pediatric data, offering a non-surgical option for severe burn injuries in children. • NexoBrid, a biologic product containing proteolytic enzymes, is now available for both adult and pediatric patients for eschar removal. • Vericel anticipates expanding its customer base to include approximately 20 pediatric burn centers in the United States.
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