Drugs / Isavuconazole
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed emergomycosis 1 milestone | |||||
| Filed | Japan (PMDA) | Cresemba | emergomycosis | 2021-09-30 | “filed a New Drug Application (NDA) for the marketing authorization of isavuconazole in Japan for the treatment of the fungal infections aspergillosis, mucormycosis and cryptococcosis.” basilea.com ↗ “At the end of September 2021, our partner, Asahi Kasei Pharma, filed a New Drug Application (NDA) for the marketing authorization of isavuconazole in Japan” basilea.com ↗ “In September 2021, Basilea’s partner Asahi Kasei Pharma filed a New Drug Application (NDA) for the marketing authorization of isavuconazole in Japan” basilea.com ↗ |
| Filed invasive aspergillosis 3 milestones | |||||
| Filed | China (NMPA) | Cresemba | invasive aspergillosis | 2020-11-25 | “the marketing authorization application (MAA) for the antifungal isavuconazole (Cresemba®) for the treatment of adult patients with invasive aspergillosis, which was submitted...” basilea.com ↗ |
| Filed | EU (EMA) | — | invasive aspergillosis | 2014-07-17 | “A European Marketing Authorization Application, submitted by Basilea, for isavuconazole for the treatment of invasive aspergillosis and mucormycosis in adults, is currently under review” basilea.com ↗ “submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole” basilea.com ↗ “This included the submission of the European Marketing Authorization application for isavuconazole in July 2014” basilea.com ↗ |
| Filed | US (FDA) | — | invasive aspergillosis | 2014-07-09 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole” astellas.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of isavuconazole” basilea.com ↗ |
| Filed Zygomycosis 1 milestone | |||||
| Filed | China (NMPA) | Cresemba | Zygomycosis | 2020-08-07 | “the marketing authorization application (MAA) for the antifungal isavuconazole (Cresemba®) for the treatment of patients with mucormycosis, which was submitted by Basilea’s...” basilea.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Cresemba | — | 2015-10-15 | europa.eu ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials | ||||||
| Phase 1 | NCT05140096 | Jan → Apr 2020 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02128893 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02128321 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01884558 | Feb 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01884636 | Feb → Mar 2013 | methotrexate toxicity, voriconazole toxicity | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01555918 | Aug → Nov 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01635946 | Aug 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657890 | Jun 2012 → Jan 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01635972 | Jun → Jul 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657825 | Jun → Jul 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01660477 | Jun → Oct 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01651325 | May 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657838 | May 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01597986 | Apr → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01582425 | Apr → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01565720 | Mar → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01582412 | Mar → May 2012 | digitalis poisoning, voriconazole toxicity | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711489 | Mar → Apr 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01555866 | Mar 2012 → Apr 2013 | impaired renal function disease | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711827 | Feb → Mar 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01535547 | Dec 2011 → Jan 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01494597 | Nov → Dec 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01809860 | Nov 2011 → Jan 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01406171 | May → Jun 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03327727 | Feb 2018 → Jan 2019 | invasive aspergillosis | Vical | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03149055 | May 2017 → Aug 2019 | myeloproliferative neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03019939 | Mar 2017 → Aug 2020 | acute myeloid leukemia, myelodysplastic syndrome, neutropenia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00413439 | May 2006 → Jun 2007 | acute myeloid leukemia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04680884 | Dec 2020 → Sep 2023 | acute respiratory failure, immunodeficiency disease | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT00634049 | Apr 2008 → Jan 2014 | aspergillosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00413218 | Mar 2007 → Mar 2015 | candidemia | Astellas Pharma Inc | Completed | Missed primary |
| Phase 3 | NCT00412893 | Mar 2007 → Mar 2013 | invasive aspergillosis | Astellas Pharma Inc | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06756191 | Jan → Jul 2025 overdue | fungal lung infectious disease | Bin Cao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05630976 | Feb 2023 → Apr 2025 | fungal infectious disease | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06440915 | Jun 2024 → Jun 2026 overdue | Zygomycosis, invasive aspergillosis | Shanghai Children's Medical Center | Recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT02203526 Background | Aug 2014 → Jul 2026 overdue | primary central nervous system lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03964090 Background | Jun 2019 → Dec 2028 expected | central nervous system non-hodgkin lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04876716 Background | May 2021 → May 2024 | invasive aspergillosis | Erasmus Medical Center | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2024-08-27 | Basilea Pharmaceutica | Regulatory European Commission Decision to approve the pediatric use of antifungal Cresemba® (isavuconazole) and extension of market exclusivity triggers CHF 10 million milestone payment to Basilea basilea.com ↗
We are very pleased to have received the European Commission Decision to approve Cresemba for the use in children who suffer from invasive aspergillosis or mucormycosis. |
| 2023-12-11 | Basilea Pharmaceutica | Regulatory Basilea announces that FDA approves expanded use of antifungal Cresemba® (isavuconazole) in the United States in children with invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Astellas Pharma US, Inc. (“Astellas”) received the approval of Cresemba® (isavuconazole) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients by the US Food and Drug Administration (FDA). |
| 2022-12-23 | Basilea Pharmaceutica | Regulatory Basilea announces regulatory approval of antifungal Cresemba® (isavuconazole) in Japan basilea.com ↗
Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Asahi Kasei Pharma (“AKP”), has received the marketing authorization from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Cresemba® (isavuconazole) for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis. |
| 2022-06-24 | Basilea Pharmaceutica | Regulatory Basilea announces approval for additional formulation of antifungal Cresemba® (isavuconazole) in China basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today that its license partner, Pfizer Inc. (NYSE: PFE, “Pfizer”), has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the intravenous formulation of Cresemba® (isavuconazole) for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. |
| 2022-01-13 | Basilea Pharmaceutica | Regulatory Basilea announces approval of antifungal Cresemba® (isavuconazole) for invasive aspergillosis in China basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, announced today that its license partner, Pfizer Inc. (NYSE: PFE, “Pfizer”), has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba® (isavuconazole) for the treatment of adult patients with invasive aspergillosis. |
| 2021-12-21 | Basilea Pharmaceutica | Regulatory Basilea receives USD 10 million milestone payment related to approval of antifungal Cresemba® (isavuconazole) in China basilea.com ↗
With this authorization, oral Cresemba is now approved in China for the treatment of adult patients with invasive mucormycosis. |
| 2021-09-30 | Basilea Pharmaceutica | Regulatory Basilea’s partner Asahi Kasei Pharma filed New Drug Application for the marketing authorization of isavuconazole in Japan basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that its partner Asahi Kasei Pharma Corporation (Asahi Kasei Pharma) has filed a New Drug Application (NDA) for the marketing authorization of isavuconazole (Cresemba®) in Japan for the treatment of the fungal infections aspergillosis, mucormycosis and cryptococcosis. |
| 2020-11-25 | Basilea Pharmaceutica | Regulatory Basilea reports acceptance for regulatory review of Pfizer’s marketing authorization application for antifungal isavuconazole (Cresemba®) in invasive aspergillosis in China basilea.com ↗
The acceptance of the isavuconazole marketing authorization applications for regulatory review is an important milestone in bringing Cresemba to the Chinese market and addressing the unmet medical needs of patients suffering from invasive mold infections. |
| 2020-08-07 | Basilea Pharmaceutica | Regulatory Basilea reports acceptance for regulatory review of Pfizer’s marketing authorization application for antifungal isavuconazole (Cresemba®) in China basilea.com ↗
has been accepted for regulatory review by the Center for Drug Evaluation at the National Medical Products Administration (NMPA) of China. |
| 2019-10-29 | Basilea Pharmaceutica | Regulatory Basilea reports marketing authorization of antifungal Cresemba® in Brazil basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its partner Grupo Biotoscana S.L. (“GBT”), received the regulatory approval and marketing authorization for the antifungal Cresemba® (isavuconazole) in Brazil. |
| 2018-08-13 | Basilea Pharmaceutica | Regulatory Basilea reports on first Cresemba® approval in MENA region basilea.com ↗
We are very pleased with the approval of Cresemba in Jordan, which will facilitate the regulatory process in other countries in the MENA region. |
| 2018-07-19 | Basilea Pharmaceutica | Regulatory Basilea reports receipt of milestone payment based on first Cresemba® approval in Latin America basilea.com ↗
We are very pleased with the approval of Cresemba in Peru. |
| 2016-04-15 | Basilea Pharmaceutica | Results Basilea reports presentation of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) basilea.com ↗
The data presented on isavuconazole included further analyses from the isavuconazole SECURE phase 3 study in invasive aspergillosis and the results of the ACTIVE phase 3 study in invasive candidiasis. |
| 2016-03-09 | Basilea Pharmaceutica | Results Basilea announces that The Lancet Infectious Diseases published results from the CRESEMBA® (isavuconazole) open-label study for the treatment of mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that results from the open-label phase 3 VITAL study evaluating CRESEMBA® (isavuconazole) in adult patients with mucormycosis were published in The Lancet Infectious Diseases. |
| 2015-10-23 | Basilea Pharmaceutica | Regulatory Basilea announces that European Commission maintained isavuconazole's orphan drug status basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the orphan drug designation of the antifungal isavuconazole for the treatment of invasive aspergillosis and mucormycosis has been maintained. |
| 2015-10-16 | Basilea Pharmaceutica | Regulatory Basilea announces that European Commission approves isavuconazole (CRESEMBA®) as a treatment for invasive aspergillosis and mucormycosis in the European Union basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the European Commission has approved the antifungal isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. |
| 2015-07-30 | Basilea Pharmaceutica | Results Basilea reports topline results of isavuconazole phase 3 study in candidemia and other invasive Candida infections basilea.com ↗
The results showed that the study did not meet the primary objective of demonstrating non-inferior efficacy of isavuconazole versus the study comparator at the end of i.v. therapy within the pre-specified non-inferiority margin. |
| 2015-07-30 | Astellas Pharma Inc | Results Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections astellas.com ↗
Results from the study demonstrated that the trial did not meet its primary endpoint of non-inferiority in overall treatment response in isavuconazole-treated patients at the end of IV therapy compared to caspofungin. |
| 2015-07-24 | Basilea Pharmaceutica | Regulatory Basilea announces that CHMP recommends approval of isavuconazole (CRESEMBA®) as a treatment for invasive aspergillosis and mucormycosis in the European Union basilea.com ↗
Today's positive CHMP opinion is a major step forward in making isavuconazole available in Europe for patients suffering from serious invasive fungal infections. |
| 2015-03-09 | Astellas Pharma Inc | Regulatory Astellas Receives FDA Approval for CRESEMBA® (isavuconazonium sulfate) for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis astellas.com ↗
“We’re pleased with the FDA’s approval of CRESEMBA for use in treating patients with these life-threatening infections,” said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. |
| 2015-03-07 | Basilea Pharmaceutica | Regulatory Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) approved Astellas' New Drug Application (NDA) for the use of isavuconazole for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). |
| 2015-01-23 | Basilea Pharmaceutica | Regulatory Basilea announces that FDA's Anti-Infective Drugs Advisory Committee recommends approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis basilea.com ↗ |
| 2014-11-03 | Basilea Pharmaceutica | Regulatory Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis/candidemia, a potentially life-threatening infection caused by Candida yeasts. |
| 2014-10-09 | Basilea Pharmaceutica | Results Basilea reports that further subgroup and health economic analyses of isavuconazole phase 3 studies will be presented at IDWeek conference basilea.com ↗
For invasive aspergillosis patients treated with isavuconazole, the difference in fewer drug-related adverse events reached statistical significance. |
| 2014-09-06 | Basilea Pharmaceutica | Regulatory Basilea's partner Astellas receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application for isavuconazole submitted by Basilea's license partner Astellas Pharma Inc. |
| 2014-08-21 | Basilea Pharmaceutica | Regulatory European Medicines Agency accepts Basilea's isavuconazole Marketing Authorization Application for review basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announces today that the European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. |
| 2014-07-17 | Basilea Pharmaceutica | Regulatory Basilea submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). |
| 2014-07-17 | Basilea Pharmaceutica | Regulatory Basilea reports that isavuconazole received QIDP designation from U.S. FDA for the treatment of invasive candidiasis basilea.com ↗
Basel, Switzerland, July 16, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts. |
| 2014-07-14 | Basilea Pharmaceutica | Regulatory Basilea reports that isavuconazole receives orphan drug designations in Europe for the treatment of invasive mold infections basilea.com ↗
Basel, Switzerland, July 14, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the European Commission granted isavuconazole orphan drug designations for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). |
| 2014-07-10 | Basilea Pharmaceutica | Regulatory Basilea's partner Astellas submits isavuconazole U.S. NDA for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that its co-development partner Astellas Pharma Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (zygomycosis). |
| 2014-07-09 | Astellas Pharma Inc | Regulatory Astellas Submits U.S. New Drug Application for Isavuconazole for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis astellas.com ↗
Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. |
| 2014-05-14 | Basilea Pharmaceutica | Results Basilea reports additional data on positive isavuconazole phase 3 SECURE study at ECCMID basilea.com ↗
Treatment emergent adverse events for isavuconazole were statistically fewer relative to the study comparator voriconazole in the System Organ Classes of hepatobiliary (8.9% vs. 16.2%), skin (33.5% vs. 42.5%) and eye disorders (15.2% vs. 26.6%). |
| 2014-02-27 | Basilea Pharmaceutica | Regulatory Basilea reports that isavuconazole receives Qualified Infectious Disease Product designation from U.S. FDA for the treatment of invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive mucormycosis (also known as zygomycosis), a life-threatening invasive fungal infection caused by certain emerging molds. |
| 2013-12-03 | Basilea Pharmaceutica | Regulatory Basilea reports that isavuconazole receives Qualified Infectious Disease Product (QIDP) designation from U.S. FDA for the treatment of invasive aspergillosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. |
| 2013-11-18 | Basilea Pharmaceutica | Regulatory Basilea reports isavuconazole orphan drug designation for treatment of zygomycosis by U.S. FDA basilea.com ↗
Basel, Switzerland, November 18, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of zygomycosis (also known as mucormycosis), a life-threatening fungal infection. |
| 2013-09-30 | Basilea Pharmaceutica | Results Basilea reports positive topline phase 3 results for antifungal isavuconazole basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE). |
| 2013-09-13 | Basilea Pharmaceutica | Results Basilea reports presentation of 19 posters at ICAAC on investigational anti-infectives isavuconazole, ceftobiprole, and BAL30072 basilea.com ↗
Isavuconazole demonstrated potent activity against global collections of contemporary, clinically relevant pathogens causing invasive fungal disease. |
| 2013-07-17 | Basilea Pharmaceutica | Regulatory Basilea provides update on isavuconazole phase 3 program basilea.com ↗
Pediatric Investigation Plans agreed by EMA |
| 2013-05-28 | Basilea Pharmaceutica | Regulatory Basilea reports isavuconazole orphan drug designation by U.S. FDA basilea.com ↗
Basel, Switzerland, May 28, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis. |
| 2013-05-28 | Astellas Pharma Inc | Regulatory Astellas announces isavuconazole orphan drug designation by U.S. FDA astellas.com ↗
Astellas Pharma Inc. (Tokyo:4503) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis. |
| 2013-04-29 | Basilea Pharmaceutica | Results Basilea reports presentation of new data on anti-infective drug candidates addressing drug resistance basilea.com ↗
In a pooled analysis of eight studies undertaken in Europe and the U.S., isavuconazole exhibited potent in-vitro activity against clinically relevant Candida isolates with reduced susceptibility to fluconazole (P 983). |
All press releases naming this drug 93 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isavuconazole | “Voriconazole or isavuconazole or posaconazole will be dosed according to the SPC and according to the route of administration (IV or orally) that is preferred by the treating physician.” NCT04876716 ↗37“IV isavuconazole (200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)” NCT04680884 ↗ “Liposomal amphotericin B (AmBisome®) combination with Isavuconazole” NCT06756191 ↗ |
| Known as | BAL-4815 | ChEMBL registry synonym — accepted as the source's own label CHEMBL409153 ↗ |
| Known as | ISAV | “Isavuconazole (ISAV) is an extended spectrum mold-active triazole and has superior tolerability and fewer significant drug-drug interactions compared with other triazoles.” PMID 32236406 ↗ May 20211“Isavuconazole (ISAV) is a novel, broad-spectrum, triazole antifungal agent (IV and by mouth [PO]) developed for the treatment of IFD.” PMID 27169478 ↗ May 2016 |
| Known as | Isavuconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL409153 ↗ |
| Action | Inhibit | “a 14-α-demethylase inhibitor” PMID 25902926 ↗ May 2015 |
| Modality | Small molecule | “Isavuconazole is a triazole with broad-spectrum antifungal activity.” PMID 37185921 ↗ Apr 2023 |
| Route | Intravenous | “Administered by intravenous infusion.” NCT00413218 ↗ |
| Target | CYP3A4 | “Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole” NCT05140096 ↗ |