Micronized progesterone

Phase 3Small molecule

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Micronized progesterone is one of 25 small molecule programs targeting Miscarriage. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

MiscarriageActive, not recruiting

Atypical Endometrial HyperplasiaActive, not recruiting

Intrauterine InseminationCompleted

ProgesteroneNot yet recruiting

HyperandrogenismRecruiting

Menopausal WomenNot yet recruiting

MiscarriagePreclinical

Active, not recruiting

Atypical Endometrial HyperplasiaPreclinical

Active, not recruiting

Intrauterine InseminationPreclinical

Completed

ProgesteronePhase 3

Not yet recruiting

HyperandrogenismPhase 1

Recruiting

Menopausal WomenPhase 1

Not yet recruiting

Competition

Competitive Landscape

8 competitors in Miscarriage

#DrugCompanyPhaseTrials

Cytotec

Pfizer

Approved

13 2

Femara

Novartis

Approved

5 3

Bayer Aspirin

Bayer

Approved

2 4

Heparin Sodium

BBaxter Healthcare Corporation

Approved

1 5

Glucophage

EMD Serono

Approved

1 6

Deltasone

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

Approved

1 7

Micronized progesterone

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

1 8

Antibiotic

Pfizer

Preclinical

1 9

Progesteron

MMinia University

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Study completion

NCT05282277

Q3 2027

Post-ApprovalNot yet recruiting

Women

NCT06856174

Q3 2028

ApprovedRecruiting

Turner Syndrome

NCT06834594

Clinical

Trials by Indication[1]

Progesterone14 trials

Progesterone and Second Trimester Bleeding

Terminated·HHaEmek Medical Center, Israel·N/A·NCT01269450·128 enrolled

Progesterone for Perimenopausal Night Sweats

Completed·UUniversity of British Columbia·Phase 3·NCT01464697·249 enrolled

Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

Completed·RReproductive Health Research Insritute, Chile·Phase 1·NCT06616077·9 enrolled

Show 11 more trials

Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow

Completed·UUniversity of British Columbia·Phase 3·NCT02779582·59 enrolled

Exogenous Progesterone as Ovulation Trigger

Not yet recruiting·IInstituto Valenciano de Infertilidade de Lisboa·Phase 4·NCT07466199·10 enrolled

Determining How Quickly Progesterone Slows LH Pulse Frequency

Completed·UUniversity of Virginia·Phase 1·NCT00594217·85 enrolled

Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)

Terminated·UUniversity of Virginia·Phase 1·NCT01602679·12 enrolled

Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

Unknown status·UUniversity of Virginia·Phase 1·NCT04597099·10 enrolled

Progesterone Treatment in Female Smokers - 12

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000295

Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.

Completed·FFundacion Dexeus·N/A·NCT04108039·44 enrolled

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

Completed·AAbbott·Phase 3·NCT01850030·1,070 enrolled

Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles

Terminated·AAndros Day Surgery Clinic·Phase 4·NCT03181685·60 enrolled

Blocking Mifepristone Action With Progesterone

Terminated·UUniversity of California, Davis·Phase 1/2·NCT03774745·12 enrolled

Progesterone Versus Progesterone Plus Dydrogesterone in FET

Completed·MMỹ Đức Hospital·N/A·NCT03998761·1,364 enrolled

Preterm Birth3 trials

Oral Progesterone for Prevention of Preterm Birth

Completed·FFetal Medicine Foundation·Phase 3·NCT01180296·36 enrolled

Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix

Terminated·HHaEmek Medical Center, Israel·N/A·NCT02329535·15 enrolled

The Value of Oral Micronized Progesterone in the Prevention of Spontaneous Preterm Birth

Unknown status·GGhamra Military Hospital·Phase 4·NCT02571296·212 enrolled

Preterm Labor3 trials

Adjunctive Vaginal Progesterone in Management of Preterm Labor

Unknown status·—·Phase 4·NCT05997563·48 enrolled

Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor

Completed·—·Phase 3·NCT02989519·231 enrolled

Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor

Terminated·WWashington University School of Medicine·N/A·NCT01840228·38 enrolled

Menopausal Women2 trials

Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS)

Not yet recruiting·MMcMaster University·Phase 1·NCT07173361·20 enrolled

The Effect of Different Types of Progestin on Sleeping of Menopausal Women

Completed·—·N/A·NCT02086032·100 enrolled

Pregnancy2 trials

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Completed·HHaEmek Medical Center, Israel·Phase 4·NCT02430233·129 enrolled

Pharmacokinetics of Progesterone in Pregnancy-2

Terminated·TThomas Jefferson University·Phase 1·NCT04753957·3 enrolled

23 more indications

Hormone Replacement Therapy2 trials

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients

Terminated·CCRG UZ Brussel·Phase 4·NCT03976544·362 enrolled

Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women

Completed·MMedical University of Vienna·Phase 4·NCT00755963·30 enrolled

Hyperandrogenism1 trial

Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

Recruiting·UUniversity of Virginia·Phase 1·NCT00929006·36 enrolled

Cocaine-dependent1 trial

Progesterone Treatment for Cocaine-dependent Women: A Pilot Study

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT00632099·21 enrolled

Suicide1 trial

Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT04112368·124 enrolled

Growth1 trial

Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women

Completed·MMayo Clinic·Phase 1·NCT02272647·47 enrolled

Suicidality1 trial

Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT03720847·30 enrolled

Endothelial Function1 trial

Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone

Unknown status·UUniversity of British Columbia·Phase 2·NCT00152438·125 enrolled

Pregnant Women1 trial

Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies

Completed·DDra.Cristina Martinez Payo·Phase 4·NCT01643980·254 enrolled

Preterm Delivery1 trial

Progestagens for the Tertiary Prophylaxis of Preterm Delivery

Completed·UUniversity of Modena and Reggio Emilia·Phase 3·NCT01178788·254 enrolled

Bulimia Nervosa1 trial

Neurobiology of Bulimia Nervosa

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT04225221·10 enrolled

Embryo Transfer1 trial

Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT03642665·554 enrolled

Frozen Embryo Transfer1 trial

Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

Completed·CCRG UZ Brussel·Phase 4·NCT04758871·150 enrolled

Intracytoplasmic Sperm Injection1 trial

Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles

Unknown status·OOne Fertility·Phase 2·NCT02677259·506 enrolled

Female1 trial

Investigation of Female Reproductive Hormone Dynamics During Adolescence

Completed·MMassachusetts General Hospital·Phase 1·NCT02486757·9 enrolled

Irritability1 trial

Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT04051320·23 enrolled

Women1 trial

Menopausal HT for Women Living With HIV (HoT)

Not yet recruiting·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT06856174·105 enrolled

Polycystic Ovarian Syndrome1 trial

Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Completed·FFundacion Dexeus·N/A·NCT03088046·15 enrolled

Intrauterine Insemination1 trial

Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Completed·UUniversitair Ziekenhuis Brussel·N/A·NCT01046708·300 enrolled

Atypical Endometrial Hyperplasia1 trial

Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia

Completed·KKocaeli University·N/A·NCT03992937·132 enrolled

Miscarriage1 trial

Non-interventional Study of Therapy for Threatened Miscarriage

Completed·BBesins Healthcare··NCT03309735·1,241 enrolled

Luteal Phase Support1 trial

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Completed·CCRG UZ Brussel·Phase 4·NCT03677336·30 enrolled

Turner syndrome1 trial

Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)

Recruiting·CChildren's Mercy Hospital Kansas City·Approved·NCT06834594·40 enrolled

Unspecified2 trials

Examining the Effects of Estradiol on Neural and Molecular Response to Reward

Recruiting·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT05282277·103 enrolled

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Recruiting·UUniversity of Virginia·Phase 1·NCT03068910·32 enrolled

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Micronized progesterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Micronized progesterone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Micronized progesterone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Micronized progesterone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q3 2028

Trials by Indication[1]

Progesterone14 trials

Preterm Birth3 trials

Preterm Labor3 trials

Menopausal Women2 trials

Pregnancy2 trials

Hormone Replacement Therapy2 trials

Hyperandrogenism1 trial

Cocaine-dependent1 trial

Suicide1 trial

Growth1 trial

Suicidality1 trial

Endothelial Function1 trial

Pregnant Women1 trial

Preterm Delivery1 trial

Bulimia Nervosa1 trial

Embryo Transfer1 trial

Frozen Embryo Transfer1 trial

Intracytoplasmic Sperm Injection1 trial

Female1 trial

Irritability1 trial

Women1 trial

Polycystic Ovarian Syndrome1 trial

Intrauterine Insemination1 trial

Atypical Endometrial Hyperplasia1 trial

Miscarriage1 trial

Luteal Phase Support1 trial

Turner syndrome1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

Related News