Drugs / EB-001
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | glabellar lines | 2026-04-23 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for trenibotulinumtoxinE” abbvie.com ↗ “received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (trenibotE)” abbvie.com ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03346902 Comparator | Feb → Jul 2018 | — | Bonti, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03193593 Comparator | Aug 2017 → Apr 2018 | musculoskeletal system disorder | Bonti, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02939326 Comparator | Dec 2016 → Jul 2017 | — | Bonti, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-17 | AbbVie | Regulatory Allergan Aesthetics receives approval for Boey® (trenibotulinumtoxinE), for use in Europe: the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients abbvie.com ↗
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the European Commission has approved Boey® (trenibotulinumtoxinE) in Europe, for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown (glabellar lines) in adult patients, when these have an important psychological impact. |
| 2026-06-23 | AbbVie | Regulatory Allergan Aesthetics receives approval for Boey® (trenibotulinumtoxinE) in Canada, the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients abbvie.com ↗
Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced Health Canada has approved Boey ® (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows (glabellar lines) in adult patients. |
| 2026-05-21 | AbbVie | Regulatory Allergan Aesthetics Receives Positive CHMP Opinion for Boey® (TrenibotulinumtoxinE) for the Temporary Improvement of Moderate to Severe Glabellar Lines in Adults abbvie.com ↗
Boey ® has received a positive opinion from the CHMP for 30 EU & EEA markets |
| 2026-04-23 | AbbVie | Regulatory AbbVie Provides Update on TrenibotulinumtoxinE (TrenibotE) Biologics License Application in the U.S. abbvie.com ↗
The CRL does not identify any safety or efficacy concerns for TrenibotE, and does not request additional clinical studies. |
| 2026-03-30 | AbbVie | Results Allergan Aesthetics Releases Findings on the Safety and Efficacy of Repeat TrenibotE Treatments and Data on Medical Weight Loss Aesthetics Patient Behaviors at the 2026 American Academy of Dermatology Meeting (AAD) abbvie.com ↗
TrenibotE is an investigational first-in-class botulinum neurotoxin serotype E characterized by rapid results, as early as 8 hours after administration (earliest assessment time), and shorter duration of effect of 2-3 weeks. |
| 2026-01-28 | AbbVie | Results Allergan Aesthetics Unveils New Data Across Facial Injectables On-Market and Emerging Portfolio at IMCAS 2026 Showcasing Enduring Strength in Advancing Aesthetics Medicine abbvie.com ↗
Pooled Phase 3 efficacy, safety and patient satisfaction data for TrenibotulinumtoxinE, a first-in-class botulinum neurotoxin serotype E that delivers rapid results with a short-duration of effect |
| 2025-11-12 | AbbVie | Results Allergan Aesthetics Unveils New Data at 2025 American Society for Dermatologic Surgery Annual Meeting Showcasing Transformative Innovation and Portfolio Excellence abbvie.com ↗
Oral abstract presentations include Phase 3 clinical study results for first-in-class botulinum neurotoxin serotype E (trenibotulinumtoxinE) |
| 2025-04-24 | AbbVie | Regulatory AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines abbvie.com ↗
AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines. |
| 2023-10-24 | AbbVie | Results Allergan Aesthetics Announces Positive Topline Results from Two Pivotal Phase 3 Studies of TrenibotulinumtoxinE (BoNT/E) for the Treatment of Glabellar Lines abbvie.com ↗
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced positive topline results from two pivotal Phase 3 clinical studies evaluating trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines (M21-500 and M21-508). |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EB-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03193593 ↗ |
| Modality | Protein / enzyme biologic | “EB-001, a Novel Type E Botulinum Toxin” PMID 30489516 ↗ Dec 2018 |
| Route | Intramuscular | “Single doses of EB- 001 administered through IM injection into procerus at midline and the medial and lateral corrugators” NCT02939326 ↗ |