Ibrexafungerp
Trade name: Brexafemme
Small moleculeapprovedFast Track FDA
Approved
Jun 1, 2021
Clinical trial activity
16 trials · 8 clinical orgs · 2 marketing orgs
Phase 1
5
Phase 2
11
Phase 3
7
Phase 4
0
Earliest trial started Sep 1, 2014 (NCT02244606)
Timeline
2010s
- Jan 1, 2014
Scynexis, Inc. — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2017
Scynexis, Inc. — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2019
Scynexis, Inc. — Earliest Phase 1 Sponsor(trial)
2020s
- Jun 1, 2021
Scynexis, Inc. — Earliest FDA Approval
- Jun 1, 2021
Scynexis, Inc. — Marketing Organization
- Jun 1, 2021
Scynexis, Inc. — NDA Secondary Org
- Jun 1, 2021
Scynexis, Inc. — NDA Organization
- Jun 1, 2021
GlaxoSmithKline — Marketing Organization
Indications
Approved for
Studied for
- Aspergillosis · Phase 3
- Aspergillosis, Allergic Bronchopulmonary · Phase 3
- Blastomycosis · Phase 3
- Candidemia · Phase 3
- Candidiasis · Phase 3
- Candidiasis, Invasive · Phase 3
- Candidiasis, Vulvovaginal · Phase 3
- Coccidioidomycosis · Phase 3
- Histoplasmosis · Phase 3
- Invasive Pulmonary Aspergillosis · Phase 3
- Mycoses · Phase 3
- Pharmacokinetics · Phase 1
- Vulvovaginitis · Phase 3
Mechanism of action
- 1,3-beta-glucan synthaseANTAGONIST
FKS antagonist
- 1,3-beta-glucan synthaseINHIBITOR
1,3-beta-glucan synthase inhibitor
- 1,3-beta-glucan synthaseINHIBITOR
1,3-beta-glucan synthase inhibitor
Approval history
- approvedPriority reviewFast trackJun 1, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)[C@@H](C)[C@@]1(C)CC[C@]2(C)[C@H]3CC[C@@H]4[C@@]5(COC[C@@]4(C)[C@@H](OC[C@](C)(N)C(C)(C)C)[C@H](n4ncnc4-c4ccncc4)C5)C3=CC[C@@]2(C)[C@@H]1C(=O)O- Mol. weight
- 730.05 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL4298168 ↗
- ChEMBLCHEMBL4297513 ↗
Also known as
- scy-078
- scy-078
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06954493 | Phase 1 | Jul 12, 2023 | Scynexis, Inc. |
| NCT05668429 | Phase 1 | Dec 31, 2022 | Scynexis, Inc. |
| NCT05178862 | Phase 3 | Aug 3, 2022 | Scynexis, Inc. |
| NCT05399641 | Phase 3 | May 1, 2022 | Scynexis, Inc. |
| NCT04307082 | Phase 1 | Dec 5, 2019 | Inncelerex, Scynexis, Inc. |
| NCT04092751 | Phase 1 | Oct 22, 2019 | Clinical Network Services, Scynexis, Inc. |
| NCT04092725 | Phase 1 | Sep 22, 2019 | Clinical Network Services, Scynexis, Inc. |
| NCT04029116 | Phase 3 | Aug 31, 2019 | Scynexis, Inc. |
| NCT03987620 | Phase 3 | Jun 7, 2019 | PPD, Scynexis, Inc. |
| NCT03734991 | Phase 3 | Jan 4, 2019 | Scynexis, Inc. |
| NCT03672292 | Phase 2 | Oct 31, 2018 | Scynexis, Inc., Syneos Health |
| NCT03363841 | Phase 3 | Nov 15, 2017 | Scynexis, Inc. |
| NCT03253094 | Phase 2 | Aug 1, 2017 | Scynexis, Inc. |
| NCT03059992 | Phase 3 | Apr 1, 2017 | Duke University, Scynexis, Inc., Sponsor GmbH |
| NCT02679456 | Phase 2 | Nov 1, 2015 | ethica Clinical Research Inc., Scynexis, Inc. |
| NCT02244606 | Phase 2 | Sep 1, 2014 | Scynexis, Inc. |
Showing 16 of 16 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Scynexis, Inc. | For profit | 16 | 16 | 3 | 2014 |
| Clinical Network Services | For profit | 2 | 0 | 1 | 2019 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| ethica Clinical Research Inc. | For profit | 1 | 0 | 1 | 2015 |
| Inncelerex | For profit | 1 | 0 | 1 | 2019 |
| PPD | For profit | 1 | 0 | 1 | 2019 |
| Sponsor GmbH | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Syneos Health | For profit | 1 | 0 | 1 | 2018 |
8 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | MKTG | Jun 1, 2021 |
| Scynexis, Inc. | For profit | MKTG | Jun 1, 2021 |
| Scynexis, Inc. | For profit | NDA2 | Jun 1, 2021 |
| Scynexis, Inc. | For profit | NDA | Jun 1, 2021 |