anacaulase
Trade name: NexoBrid
Approved
Dec 28, 2022
Bromelain is an enzyme extract derived from the stems of pineapples, although it exists in all parts of the fresh plant and fruit. The extract has a history of folk medicine use. As a culinary ingredient, it may be used as a meat tenderizer. — Wikipedia
Clinical trial activity
28 trials · 33 clinical orgs · 1 marketing orgs
Earliest trial started Sep 30, 1996 (NCT03470337)
Timeline
1990s
- Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
2000s
- Aug 20, 2003
Orphan Drug Designation
2020s
- Dec 28, 2022
MediWound Ltd — Earliest FDA Approval
- Dec 28, 2022
MediWound Ltd — Marketing Organization
- Dec 28, 2022
MediWound Ltd — NDA Secondary Org
- Dec 28, 2022
MediWound Ltd — NDA Organization
Indications
Approved for
Studied for
- Adenocarcinoma, Mucinous · Phase 1/Phase 2
- Bacterial Infections · Early Phase 1
- Breast Neoplasms · Phase 4
- Bromelains · Early Phase 1
- Burns · Phase 3
- Calcium Hydroxide · Early Phase 1
- Cough · Phase 4
- COVID-19 · Phase 4
- Dental Caries · Phase 2
- Dental Plaque · Phase 2
- Diabetic Foot · Phase 3
- Drug Delivery Systems · Early Phase 1
- Hamartoma · Phase 1/Phase 2
- Hyperuricemia · Phase 4
- Lichen Planus, Oral · Phase 2
- Neoplasms · Phase 2
- Periodontal Pocket · Phase 1
- Pneumonia, Ventilator-Associated · Phase 1/Phase 2
- Postoperative Pain · Phase 4
- Prostatic Neoplasms · Phase 2
- Pseudomyxoma Peritonei · Phase 1/Phase 2
- Pulpitis · Phase 2
- Stomatitis, Aphthous · Phase 2
- Thrombophlebitis · Phase 3
Mechanism of action
- Unspecified targetOTHER
Unknown
The antiedematous, antiinflammatory, antithrombotic and fibrinolytic efficacy of bromelain suggests that several mechanisms of action are involved on different levels (see PMID: 11577981)
- Unspecified targetOTHER
Removal of necrotic tissue
The mechanism is not fully understood but thiol endopeptidases and escharase are present and may promote wound healing by removing necrotic tissue.
Approval history
- approvedDec 28, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaBromelain ↗
- NCATSK0H66D72UT ↗
- WikipediaStem bromelain ↗
- ChEMBLCHEMBL4298054 ↗
- NCATSZLM4P8929R ↗
- NCATSU182GP2CF3 ↗
- ChEMBLCHEMBL2109027 ↗
Also known as
- ananase
- bromelain
- bromelain
- bromelain
- bromelains
- bromelains
- bromelain, stem
- bromelin
- bromelin
- concentrate of proteolytic enzymes enriched in bromelain
- nexobrid
- nexobrid
- stem bromelain
- stem bromelain
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07115212 | N/A | Sep 8, 2025 | University of Kentucky |
| NCT06993337 | Phase 2 | Jun 15, 2025 | Cairo University |
| NCT06981767 | Phase 2 | Jun 15, 2025 | Cairo University |
| NCT07185386 | N/A | May 28, 2025 | Ekalab S.r.l. |
| NCT06786403 | Phase 3 | Mar 31, 2025 | National Nutrition and Food Technology Institute |
| NCT06505759 | Phase 1 | Jul 31, 2024 | Krishnadevaraya College of Dental Sciences & Hospital |
| NCT06298383 | N/A | Mar 15, 2024 | Cairo University, Egyptian Russian University |
| NCT06775392 | Phase 1 | Jan 4, 2024 | Krishnadevaraya College of Dental Sciences & Hospital |
| NCT05687760 | Early Phase 1 (Phase 1) | Feb 10, 2023 | Cairo University |
| NCT05349929 | Phase 2 | May 31, 2022 | Qazvin University Of Medical Sciences |
| NCT05258682 | Phase 1/Phase 2 (Phase 2) | May 1, 2022 | Mucpharm Pty Ltd, University of New South Wales |
| NCT04982146 | Phase 1 | Sep 13, 2021 | Hospital Universitario Reina Sofía, Universidad de Cordoba |
| NCT04669119 | Phase 4 | Dec 31, 2020 | University of Bari |
| NCT04657874 | N/A | Dec 1, 2020 | University of L'Aquila |
| NCT04468139 | Phase 4 | Jun 20, 2020 | Government of Netherlands, Government of Saudi Arabia |
| NCT04252625 | Phase 2 | Apr 30, 2020 | University of Utah |
| NCT04664712 | N/A | Sep 11, 2019 | ASL Bari, University of Bari |
| NCT03976973 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2019 | Mercy Medical Center, Mucpharm Pty Ltd, ThermaSolutions Inc., University of New South Wales, Wake Forest University |
| NCT03586232 | N/A | Nov 30, 2018 | Boston University |
| NCT04161872 | Phase 4 | Oct 1, 2018 | University of Pavia |
Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cairo University | Academic/Hospital | 4 | 4 | 3 | 2023 |
| MediWound Ltd | For profit | 3 | 3 | 2 | 2014 |
| Krishnadevaraya College of Dental Sciences & Hospital | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Mucpharm Pty Ltd | For profit | 2 | 2 | 1 | 2019 |
| University of Bari | Academic/Hospital | 2 | 1 | 2 | 2019 |
| University of New South Wales | Academic/Hospital | 2 | 0 | 1 | 2019 |
| ASL Bari | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Boston University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Delta Dental Foundation | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Egyptian Russian University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Ekalab S.r.l. | For profit | 1 | 1 | 1 | 2025 |
| Federal University of Pernambuco | Academic/Hospital | 1 | 1 | 1 | 2011 |
| GCP-Service International Ltd. & Co. KG | For profit | 1 | 0 | 1 | 2014 |
| Government of Netherlands | Government | 1 | 0 | 1 | 2020 |
| Government of Saudi Arabia | Government | 1 | 1 | 1 | 2020 |
| Hebei University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Hospital Universitario Reina Sofía | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| London South Bank University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Mercy Medical Center | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| MediWound Ltd | For profit | MKTG | Dec 28, 2022 |
| MediWound Ltd | For profit | NDA2 | Dec 28, 2022 |
| MediWound Ltd | For profit | NDA | Dec 28, 2022 |