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Depo-Provera

(medroxyprogesterone)

ApprovedSmall molecule

This medication is a hormone injection used to prevent pregnancy by stopping the release of eggs from the ovaries and thickening the uterine lining. It is also used to treat endometriosis, a painful condition where tissue similar to the uterine lining grows in other areas of the body.[2] Depo-Provera is currently approved and in use across 3 indications[4].[1]

Depo-Provera is one of 115 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

3

Indications

16

Total Trials

0

Active Trials

114

Competitors

38

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

CognitionActive, not recruiting

Venous MalformationUnknown status

Systemic Lupus ErythematosusPreclinical

Active, not recruiting

CognitionPreclinical

Active, not recruiting

Venous MalformationApproved

Unknown status

Competition

Competitive Landscape

134 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Rituxan

Medrol

Rinvoq

Cytoxan

BBaxter Healthcare Corporation

Gazyva

Depo-Provera

Sotyktu

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Rapamune

PPrism Pharmaceuticals

Ianalumab

Glucocorticoid

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

Clinical

Trials by Indication[1]

Endometrial Cancer2 trials

Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00033358·52 enrolled

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Terminated·GGynecologic Oncology Group·Phase 2·NCT00003179·360 enrolled

Atherosclerosis2 trials

Estrogen and Graft Atherosclerosis Research Trial (EAGER)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000605

Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000559

Breast Cancer2 trials

S9630, Medroxyprogesterone in Treating Women With Breast Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00002920·313 enrolled

Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00026286

Polycystic Ovarian Syndrome1 trial

Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

Completed·YYale University·N/A·NCT00743574·36 enrolled

Venous malformation1 trial

Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

Unknown status·HHaEmek Medical Center, Israel·Phase 4·NCT05491343·28 enrolled

8 more indications

Cognition1 trial

Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

Completed·UUniversity of Colorado, Denver·N/A·NCT02122198·17 enrolled

Hot flashes1 trial

Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00030914·227 enrolled

Alzheimer's Disease1 trial

Alzheimer's Disease: Therapeutic Potential of Estrogen

Completed·UUniversity of Wisconsin, Madison·Phase 2/3·NCT00066157·42 enrolled

Systemic Lupus Erythematosus1 trial

Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006133·970 enrolled

Kidney Cancer1 trial

Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer

Completed·CCentre Leon Berard·Phase 3·NCT00416429·456 enrolled

Estrogen Replacement Therapy1 trial

Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 3·NCT00004650·150 enrolled

Adenocarcinoma1 trial

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Completed·GGynecologic Oncology Group·Phase 2·NCT00064025·75 enrolled

Estrogen1 trial

Postmenopausal Estrogen/Progestin Interventions (PEPI)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000466

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PROVERA

NDA NDA011839

Jan 1, 1982

DEPO-PROVERA

NDA NDA012541

Oct 29, 1992

DEPO-PROVERA

NDA NDA020246

Oct 29, 1992

DEPO-PROVERA

NDA NDA020246

Feb 17, 1994

DEPO-PROVERA

NDA NDA020246

Dec 1, 1994

DEPO-PROVERA

NDA NDA020246

Dec 1, 1994

DEPO-PROVERA

NDA NDA020246

May 3, 1995

DEPO-PROVERA

NDA NDA020246

Nov 28, 1995

DEPO-PROVERA

NDA NDA020246

Feb 1, 1996

DEPO-PROVERA

NDA NDA020246

Mar 20, 1996

DEPO-PROVERA

NDA NDA020246

Jan 31, 1997

DEPO-PROVERA

NDA NDA020246

Aug 12, 1998

DEPO-PROVERA

NDA NDA020246

Apr 3, 2000

DEPO-PROVERA

NDA NDA020246

Jun 7, 2001

DEPO-PROVERA

NDA NDA020246

Apr 26, 2002

DEPO-PROVERA

NDA NDA020246

May 23, 2002

DEPO-PROVERA

NDA NDA020246

May 23, 2003

DEPO-PROVERA

NDA NDA020246

Nov 17, 2004

DEPO-PROVERA

NDA NDA020246

Dec 17, 2004

DEPO-SUBQ PROVERA 104

NDA NDA021583

Oct 28, 2005

DEPO-PROVERA

NDA NDA020246

Oct 15, 2010

DEPO-PROVERA

NDA NDA020246

Jul 28, 2011

DEPO-PROVERA

NDA NDA020246

Mar 25, 2013

DEPO-PROVERA

NDA NDA020246

Sep 10, 2013

DEPO-PROVERA

NDA NDA020246

Sep 27, 2013

DEPO-PROVERA

NDA NDA020246

Jun 9, 2014

DEPO-PROVERA

NDA NDA020246

Jan 23, 2015

DEPO-PROVERA

NDA NDA020246

Jan 30, 2015

DEPO-PROVERA

NDA NDA020246

Feb 24, 2016

DEPO-PROVERA

NDA NDA020246

Dec 16, 2016

DEPO-PROVERA

NDA NDA020246

Mar 16, 2017

DEPO-PROVERA

NDA NDA020246

Sep 9, 2020

DEPO-PROVERA

NDA NDA020246

Sep 9, 2020

DEPO-PROVERA

NDA NDA020246

Dec 4, 2020

DEPO-PROVERA

NDA NDA020246

Dec 4, 2020

DEPO-PROVERA

NDA NDA020246

Jul 11, 2024

DEPO-PROVERA

NDA NDA020246

Dec 12, 2025

DEPO-PROVERA

NDA NDA020246

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for medroxyprogesterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Depo-Provera drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — medroxyprogesterone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for medroxyprogesterone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020246). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

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