Drospirenone

(drospirenone)

ApprovedSmall molecule

EExeltis France

Drospirenone is one of 92 small molecule programs targeting Adenomyosis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

AdenomyosisActive, not recruiting

HypertensionActive, not recruiting

Advanced MalignanciesRecruiting

EndometriosisActive, not recruiting

AdenomyosisPreclinical

Active, not recruiting

HypertensionApproved

Active, not recruiting

Advanced MalignanciesPhase 1

Recruiting

EndometriosisPreclinical

Active, not recruiting

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Drospirenone

EExeltis France

Approved

1 2

Edarbi

Takeda

Preclinical

10 3

Benicar

Novartis

Preclinical

7 4

Apresoline

Novartis

Preclinical

7 5

Edarbi

Takeda

Preclinical

4 6

Alphagan

AbbVie

Preclinical

—7

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 8

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Hypertension

NCT07293728

Q2 2028

Phase 1Recruiting

Advanced Malignancies

NCT07340190

Clinical

Trials by Indication[1]

Bariatric Surgery2 trials

Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study

Recruiting·—·Phase 1/2·NCT06345560·16 enrolled

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

Recruiting·—·N/A·NCT06345586·16 enrolled

Overweight1 trial

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06039826·46 enrolled

Efficacy1 trial

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

Completed·IInsud Pharma·Phase 3·NCT05461573·1,542 enrolled

Adenomyosis1 trial

Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis

Unknown status·UUniversity of Palermo··NCT06174792·40 enrolled

Observational Study1 trial

Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study

Recruiting·OOspedale Policlinico San Martino··NCT07061093·96 enrolled

5 more indications

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05706753·20 enrolled

Hypertension1 trial

A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia

Not yet recruiting·OOregon Health and Science University·Phase 4·NCT07293728·50 enrolled

Advanced Malignancies1 trial

A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

Recruiting· Novartis logo

Novartis·Phase 1·NCT07340190·24 enrolled

Regulatory

FDA Approval Timeline[4]

May 23, 2019

SLYND

NDA NDA211367

Jun 29, 2022

DROSPIRENONE

NDA NDA216285

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for drospirenone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — drospirenone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for drospirenone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216285). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Drospirenone. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Exeltis France company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: EExeltis France

Patent Landscape[5]

Patent Cliff

Jun 28, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10179140Jun 28, 2031

10603281Jun 28, 2031

10849857Jun 28, 2031

12090231Jun 28, 2031

9603860Jun 28, 2031

11 more patents

11413249Jun 28, 2031

11951213Jun 28, 2031

11351122Jun 28, 2031

11478487Jun 28, 2031

11123299Jun 28, 2031

11439598Jun 28, 2031

11504334Jun 28, 2031

10987364Jun 28, 2031

11291632Jun 28, 2031

11291633Jun 28, 2031

12280151Jun 28, 2031

Drospirenone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Trials by Indication[1]

Bariatric Surgery2 trials

Overweight1 trial

Efficacy1 trial

Adenomyosis1 trial

Observational Study1 trial

Endometriosis1 trial

Active Surveillance1 trial

Female1 trial

Hypertension1 trial

Advanced Malignancies1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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