Mycoses

9
Pipeline Programs
4
Companies
28
Clinical Trials
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
1
0
1
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 4 programs with unclassified modality

On Market (6)

Approved therapies currently available

Pfizer
DIFLUCANApproved
fluconazole
Pfizer
oral1990
Pfizer
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERApproved
fluconazole
Pfizer
injection1990
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9%Approved
fluconazole
Pfizer
injection1990
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERApproved
fluconazole
Pfizer
injection1990
U
FLUCONAZOLEApproved
fluconazole
Unknown Company
Azole Antifungal [EPC]oral2023
U
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERApproved
fluconazole
Unknown Company
injection2010

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
1
FluconazolePhase 3Small Molecule5 trials
Active Trials
NCT00002112Completed
NCT00002277Completed
NCT00000627Completed90Est. Nov 1994
+2 more trials
Scynexis
ScynexisJERSEY CITY, NJ
1 program
1
SCY-078Phase 21 trial
Active Trials
NCT02244606CompletedEst. Aug 2016
GSK
GSKLONDON, United Kingdom
1 program
1
Terbinafine 250 mgPhase 11 trial
Active Trials
NCT01772212Completed30Est. Mar 2011
M&
Merck & Co.RAHWAY, NJ
2 programs
Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and OutcomeN/A1 trial
Standard CareN/A1 trial
Active Trials
NCT02683642Completed420Est. Sep 2017
NCT01254318Completed130Est. Nov 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
PfizerFluconazole
PfizerFluconazole
PfizerFluconazole
PfizerFluconazole
PfizerFluconazole
ScynexisSCY-078
PfizerFluconazole
PfizerFluconazole
GSKTerbinafine 250 mg
PfizerFluconazole
PfizerFluconazole
Merck & Co.Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome
Merck & Co.Standard Care
PfizerFluconazole

Clinical Trials (28)

Total enrollment: 2,211 patients across 28 trials

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

Est. completion: Nov 1993500 patients
Phase 3Completed

A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

Phase 3Completed

Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

330 patients
Phase 3Completed

A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

100 patients
Phase 3Completed

The Study Of Fluconazole For Vulvovaginal Candidiasis

Start: Mar 2013Est. completion: Nov 2013157 patients
Phase 3Completed

A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

Start: Dec 2010Est. completion: Nov 201117 patients
Phase 3Terminated

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Start: Feb 2009Est. completion: Feb 201870 patients
Phase 3Completed

A Study Of Diflucan In Children With Ringworm Of The Scalp

Start: Nov 2002Est. completion: Mar 2003185 patients
Phase 3Completed

Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Start: Sep 2014Est. completion: Aug 2016
Phase 2Completed

Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

Start: Jun 2019Est. completion: Jul 201936 patients
Phase 1Completed

Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.

Start: Sep 2018Est. completion: Dec 201824 patients
Phase 1Completed
NCT01772212GSKTerbinafine 250 mg

Bioequivalence Study for Terbinafine 250 mg

Start: Feb 2011Est. completion: Mar 201130 patients
Phase 1Completed

The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Start: May 2009Est. completion: Jul 200928 patients
Phase 1Completed

A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

N/ACompleted

Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

N/ACompleted

A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

N/ACompleted

A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

64 patients
N/ACompleted

Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

N/ACompleted

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

N/ACompleted

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

N/ACompleted

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

N/ACompleted

Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

Est. completion: Nov 199490 patients
N/ACompleted

A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

N/ACompleted

Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

N/ACompleted

A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common

N/ACompleted
NCT02683642Merck & Co.Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome

Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome

Start: Apr 2016Est. completion: Sep 2017420 patients
N/ACompleted

Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)

Start: Mar 2013Est. completion: Nov 2014130 patients
N/ACompleted

Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

Start: Nov 2012Est. completion: Oct 201430 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
4 companies competing in this space