Fludrocortisone Acetate

Phase 3Small molecule

Fludrocortisone Acetate is one of 50 small molecule programs targeting Prostate Cancer Metastatic. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Prostate Cancer MetastaticRecruiting

Prostatic Neoplasms, Castration-ResistantRecruiting

Prostate CancerActive, not recruiting

Prostate Cancer MetastaticPhase 3

Recruiting

Prostatic Neoplasms, Castration-ResistantPreclinical

Recruiting

Prostate CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Androgen Deprivation Therapy

Johnson & Johnson

Phase 3

48 2

Acetylsalicylic Acid

Bayer

Phase 3

2 3

Triptorelin Embonate

Ipsen

Phase 3

3 4

Lhrha

Johnson & Johnson

Phase 3

2 5

Docetaxel /m²

AstraZeneca

Phase 3

2 6

Fludrocortisone Acetate

Merck & Co.

Phase 3

1 7

Luteinizing Hormone Releasing Hormone

UUS Department of Veterans Affairs

Phase 3

2 8

Lupron Depot

RRepros Therapeutics Inc.

Phase 3

2 9

Trexall

Duragesic

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2029

PreclinicalRecruiting

Prostatic Neoplasms, Castration-Resistant

NCT06353386

Q1 2030

Phase 3Recruiting

Prostate Cancer Metastatic

NCT06136624

Q4 2030

Phase 3Recruiting

Metastatic Castration-Resistant Prostate Cancer, Mcrpc

NCT06136650

Clinical

Trials by Indication[1]

Interaction2 trials

A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06554639·12 enrolled

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06633419·14 enrolled

Vasovagal syncope2 trials

Midodrine and Fludrocortisone for Vasovagal Syncope

Unknown status·TTehran Heart Center·Phase 3·NCT04595942·1,375 enrolled

Clinical Trial for the Prevention of Vasovagal Syncope

Completed·UUniversity of Calgary·Phase 4·NCT00118482·213 enrolled

Septic Shock1 trial

Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS

Completed·TThe George Institute·Phase 2·NCT04494789·155 enrolled

End Stage Renal Disease (ESRD)1 trial

A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06814132·24 enrolled

COVID-191 trial

Mineralocorticoid Use in COVID-19 Patients

Completed·—·Phase 3·NCT05453214·10 enrolled

6 more indications

Prostate Cancer1 trial

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06104449·6 enrolled

Moderate Hepatic Impairment1 trial

A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06860243·16 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136650·1,314 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06353386·220 enrolled

Prostate Cancer Metastatic1 trial

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136624·1,310 enrolled

Unspecified1 trial

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07548606·14 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Fludrocortisone Acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fludrocortisone Acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fludrocortisone Acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Fludrocortisone Acetate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q1 2030

Q4 2030

Trials by Indication[1]

Interaction2 trials

Vasovagal syncope2 trials

Septic Shock1 trial

End Stage Renal Disease (ESRD)1 trial

COVID-191 trial

Prostate Cancer1 trial

Moderate Hepatic Impairment1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

Prostate Cancer Metastatic1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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