Antifungal preclinical and clinical pipeline review

Published: April 2025

The first WHO global pipeline review of antifungal therapeutic products in clinical and preclinical development captures 43 antifungal products as of 30 September 2024.

Candidate products are reported by country and region of development, income group by country GDP, size and type of developer, stage of development, details of pathogen-specific products and spectrum of activity, clinical indication being targeted, route of administration, novelty, and mode of action. Some characteristics of the products are also reported such as whether the product is new or repurposed, is a new chemical class or if it has a new mechanism of action.

See also:

What you see | Scope, analysis and limitations | Data sources | Previous versions

You may view clinical and preclinical products separately by selecting the corresponding tab at the top of the dashboard.

What you see

The data visualization shows the numbers of antibacterial products by:

• Developer details (for novel clinical agents in phases 1-3 and all preclinical agents) (Panel A), including number by geographical distribution of WHO region/country (chart A.1), income group (chart A.2), size of developer institution (chart A.3) and developer type (chart A.4) (hover over the circles in the panel A map for details on the region and number of products)
• stage of development (Panel B), in novel clinical or preclinical products (chart B.1). Chart B.2 describes clinical products by their status as novel, label extension, repurposed or approved
• expected activity (Panel C) for novel preclinical (chart C.1a) and clinical (chart C.1b) agents and against fungal priority pathogens classified as critical (CPP) vs. high or medium (indicated as other priority pathogens, OPP) (chart C.1)
• indication (Panel D) for approved agents (chart D.1), or sought indications in label extensions (chart D.2) and novel agents (chart D.3) (hover over the donut charts in D.2 and D.3 for indication details)
• route of administration (Panel E) for preclinical (chart E.1) and clinical (chart E.2) agents
• novelty/innovation (Panel F) in preclinical (chart F.1) and clinical (chart F.2) agents and for new clinical agents whether innovative (chart F.3)
• new product type (Panel G) for preclinical agents (chart G.1) and by clinical class (chart G.2)
• mode of action (Panel H) in new preclinical (chart H.1) and clinical (chart H.2) candidates
• list of products or programmes with further information on each product (Panel I).

Points to note

• As of 30 September 2024, a total of 43 antifungals are in the clinical and preclinical antifungal pipeline. 21 antifungal agents are in clinical development and 22 in preclinical development (click on clinical or preclinical tab to view these separately)
• Of the 21 clinical antifungal agents, 9 are novel, 8 represent label extensions, and 4 are repurposed drugs (chart B.2)
• For the 31 the novel clinical and preclinical agents, 17 (51.5%) entities based in the Region of the Americas are advancing their development, followed by 10 (30.3%) in the European Region (chart A.1). Notably, 31 (94%) of these developers are located in high-income countries (refer to chart A.2) (please note that some agents are being developed through multi-agency collaborations; this is why the total # of institutions vary)
• There are 18 institutions advancing 22 preclinical programmes. Most preclinical products (59%; 13), are being developed by private institutions, followed by academic institutions (31.8%%; 7) and public institutions (9%; 2) (chart A.4)
• Of the preclinical commercial institutions (private and public, 12 total) most are micro (<10 employees) and small (11-50 employees) entities (click on private or public in chart A.4 to view these numbers in chart A.3)
• Of the 9 novel agents in clinical development, three agents are in phase 3, two in phase 2 and four in phase 1 (chart B.1)
• In the past 10 years, only 4 antifungal agents have reached market approval by a stringent regulatory authority (chart B.2)
• The preclinical agents’ activities against fungal priority pathogens are featured in chart C1.a
• 7 of the 9 novel clinical agents target critical priority pathogens (click the Clinical tab at the top of the page and scroll down to chart C.1) A summary of the activity of these agents can be viewed in chart C1.b, where a single agent may be active against more than one critical, or other priority pathogen (high or medium; OPP)
• The indications of market authorized agents include invasive aspergillosis, vulvovaginal candidiasis, mucormycosis and invasive candidiasis (chart D.1)
• Intravenous is the most common route of administration in both preclinical (chart E.1) and clinical (chart E.2) antifungal agents under development
• 16 preclinical products (72.7%) are direct-acting of which 14 are small molecules and 2 are antifungal peptides (chart G.1)
• The top mode of action in preclinical programmes is ‘cell wall biogenesis’ (5) (chart H.1), while azole inhibition of Fungal ERG11/Cyp51s and CYP51B inhibitor’ (2) is top in clinical agents (chart H.2)
• There are no non-traditional antifungal agents currently in clinical development; while there are 6 non-traditional agents in preclinical development stages (Panel I, column 2).

To explore the data further

• Select a stage of development, route of administration, pathogen, or another element (e.g., by clicking on a bar in a chart or a cell in a table) – or a combination of elements– to display the corresponding data in the other charts.
• Hover the cursor on a bar, a slice in a pie chart or a cell in a table to see more information in a popup window.
• Hold the ‘Ctrl’ key on your keyboard to select more than one option.
• Undo a selection by clicking ‘undo’ or ‘reset’ near the bottom of the page or by clicking the same element again.

Scope, analysis and limitations of the data

Scope

This antifungal clinical and preclinical pipeline analysis focuses on products developed to address drug-resistant infections caused priority pathogen according to the WHO fungal priority pathogen list that are in clinical (Phase 1, 2, 3 or NDA/MAA) or preclinical (lead-optimization (post hit expansion), preclinical candidate, to formal Investigational New Drug Application (IND). IND is also termed as a Clinical Trial Application (CTA)) stages.

The review includes both traditional and non-traditional products:

• direct- and indirect-acting antifungals;
• small and large molecules;
• antivirulence agents;
• biofilm disruptors;
• potentiators;
• microbiome modifying agents;
• immunomodulators;
• repurposed agents
• de-colonisation agents;
• combination therapies.

The review does not include:

• vaccines;
• topical decolonising agents;
• non-specific inorganic substances;
• biodefence agents; agents only developed for topical application (e.g., creams or eye drops)
• new formulations of existing treatments;
• authorised antibacterials that are being repurposed. 

Analysis

• The analysis was conducted by the WHO IRC Team. The WHO Advisory Group on the R&D of Antifungal              Treatments was also consulted and comprised of clinicians, mycologists, and leading experts in antifungal R&D, pharmacokinetics/pharmacodynamics (PK/PD) and antimicrobial resistance.
• Products under development (at or in the three years prior to the review) were assessed against the available evidence of activity against the WHO fungal priority pathogens list. Assessment for use against OPPs was done for products not active against critical priority pathogens.

Limitations of the data

The report relies on data available in the public domain and input from the WHO Technical Advisory Group on R&D.

Particularly, the analysis and assessment of the preclinical pipeline relies largely on data submitted by the respective developers through the open WHO data call. When available other sources were used for additional information, or the developer was contacted for clarification.

The WHO Secretariat welcomes any additional information and/or feedback on the data presented in this document, which should be sent to: antifungalpipeline@who.int for incorporation in subsequent reviews.

Data sources

First version