Drugs / Amphotericine B
Amphotericine B
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | AmBisome | Cryptococcal meningitis | 1999-07-06 | “submitted a Supplemental New Drug Application (sNDA) for the anti-fungal agent AmBisome to the U.S. Food and Drug Administration (FDA) on July 6, 1999” gilead.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00391014 | Jan 2006 → Dec 2008 | acute myeloid leukemia, disease related to hematopoietic stem cell transplant | PETHEMA Foundation | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04839653 | May 2021 → Apr 2022 | acute respiratory distress syndrome, bacterial infectious disease, infectious disease with sepsis, pneumonia | MEDSI Clinical Hospital 1, ICU | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Shionogi | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis shionogi.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2026-06-18 | F2G Ltd | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis f2g.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2025-03-03 | TLC Biopharmaceuticals, Inc. | Regulatory TLC BioSciences Secures Marketing Approval for Ampholipad® in China tlcbio.com ↗
Following the approval of AmBisome in China in 2023, TLC demonstrated the quality and bioequivalence of Ampholipad to AmBisome within two years, obtaining NMPA approval. |
| 2024-03-22 | Matinas BioPharma Nanotechnologies, Inc. | Results Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response matinasbiopharma.com ↗
The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options. |
| 2021-05-27 | Halcygen Pharmaceuticals Limited | Regulatory TLC and Strides partner to launch Liposomal Amphotericin B in India strides.com ↗
TLC receives approval from Central Drugs Standard Control Organization of India to launch Amphotericin B Liposome for Injection 50mg |
| 2019-01-16 | Drugs for Neglected Diseases | Results Combination therapy found to be more effective in treating patients with leishmaniasis and HIV | DNDi dndi.org ↗ |
| 2000-11-17 | Gilead Sciences | Results Study Results Published in Journal of Clinical Infectious Diseases Demonstrate That Ambisome® Has an Improved Safety Profile Compared to Abelcet® gilead.com ↗
Results of the study indicate that AmBisome demonstrates an improved safety profile in a direct comparison with Abelcet with regard to nephrotoxicity and infusion-related reactions. |
| 1999-09-27 | Gilead Sciences | Results AmBisome® Phase III Study For Cryptococcal Meningitis gilead.com ↗
The study results indicate that AmBisome is as effective as amphotericin B, yet appears to be significantly less toxic. |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amphotericine B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00391014 ↗ |
| Known as | AMBISOME | “The Nebulized Liposomal Amphotericin B (Ambisome) prophylaxis against IPA has shown good tolerance, safety and efficacy in lung transplant recipients.” NCT00391014 ↗ |
| Known as | Liposomal Amphotericin B | “The Nebulized Liposomal Amphotericin B (Ambisome) prophylaxis against IPA has shown good tolerance, safety and efficacy in lung transplant recipients.” NCT00391014 ↗ |