Product Description
Astodrimer gel is a novel drug which demonstrated favourable outcomes for treatment of patients with bacterial vaginosis. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33749959/)
Mechanisms of Action: Bacterial Growth Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Vaginal, Nasal, Topical
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Australia | United Arab Emirates
Approved Indications: None
Known Adverse Events: None
Company: Starpharma Pty
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Vaginosis, Bacterial|Vaginal Diseases
Phase 2: Herpes Genitalis|HIV Infections|Vaginosis, Bacterial|Vaginal Diseases
Phase 1: Acquired Immunodeficiency Syndrome|HIV Infections|Herpes Simplex|COVID-19
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT00490152 |
ATN 062 | N/A |
Completed |
HIV Infections |
2009-11-01 |
2019-03-21 |
Treatments |
|
ACTRN12620001371987 |
ACTRN12620001371987 | P1 |
Completed |
COVID-19 |
2021-03-08 |
2024-08-29 |
Treatments |
|
NCT00442910 |
MTN-004; SPL7013-006 | P1 |
Completed |
HIV Infections |
2009-12-01 |
2019-03-21 |
Treatments |
|
NCT00331032 |
SPL7013-004 | P1 |
Completed |
Herpes Simplex |
2007-11-01 |
2019-03-21 |
Treatments |
|
NCT00370357 |
SPL7013-002 | P1 |
Completed |
Acquired Immunodeficiency Syndrome|HIV Infections |
2007-02-01 |
2019-03-21 |
Treatments |
|
ACTRN12606000385549 |
Starpharma Protocol Number SPL7013-002 | P1 |
Completed |
HIV Infections |
None |
2024-04-03 |
Treatments |
|
NCT01437722 |
SPL7013-014 | P2 |
Completed |
Vaginosis, Bacterial|Vaginal Diseases |
2012-12-01 |
2019-03-19 |
Treatments |
|
NCT01201057 |
SPL7013-013 | P2 |
Completed |
Vaginal Diseases|Vaginosis, Bacterial |
2011-03-01 |
2019-03-19 |
Treatments |
|
NCT00740584 |
SPL7013-003 | P2 |
Completed |
HIV Infections|Herpes Genitalis |
2009-03-01 |
2019-03-18 |
||
NCT02237950 |
SPL7013-017 | P3 |
Completed |
Vaginosis, Bacterial|Vaginal Diseases |
2016-12-09 |
2019-03-22 |
Treatments |
|
2014-000694-39 |
Harmony | P3 |
Completed |
Vaginosis, Bacterial |
2016-09-09 |
2022-03-13 |
Treatments |
|
NCT02236156 |
SPL7013-018 | P3 |
Completed |
Vaginal Diseases|Vaginosis, Bacterial |
2016-07-04 |
2019-03-20 |
Treatments |
|
2012-000752-33 |
2012-000752-33 | P3 |
Completed |
Vaginosis, Bacterial |
2012-10-05 |
2022-03-13 |
Treatments |
|
NCT01577537 |
SPL7013-016 | P3 |
Completed |
Vaginosis, Bacterial|Vaginal Diseases |
2012-10-05 |
2019-03-19 |
Treatments |
|
NCT01577238 |
SPL7013-015 | P3 |
Completed |
Vaginal Diseases|Vaginosis, Bacterial |
2012-07-20 |
2019-03-19 |