Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Activella

(Estrogen)

ApprovedSmall molecule

This medication combines two female hormones to relieve menopausal symptoms like hot flashes and vaginal dryness by replacing the estrogen the body no longer produces. It also helps strengthen bones to prevent osteoporosis, and progestin is added to reduce the risk of uterine cancer in women who still have their uterus.[2] Activella is currently approved and in use across 19 indications[4].[1]

Activella is one of 251 small molecule programs targeting Turner syndrome. It is currently in Approved.

19

Indications

56

Total Trials

14

Active Trials

250

Competitors

17

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Turner SyndromeActive, not recruiting

Anorexia NervosaRecruiting

MortalityActive, not recruiting

Stress Urinary IncontinenceActive, not recruiting

Premature Ovarian InsufficiencyRecruiting

COVID-19Active, not recruiting

ObesityActive, not recruiting

Chronic Pelvic PainActive, not recruiting

AgingCompleted

Hyaluronic AcidNot yet recruiting

Turner SyndromePreclinical

Active, not recruiting

Anorexia NervosaPhase 2

Recruiting

MortalityPreclinical

Active, not recruiting

Stress Urinary IncontinencePreclinical

Active, not recruiting

Premature Ovarian InsufficiencyPhase 3

Recruiting

COVID-19Preclinical

Active, not recruiting

ObesityPreclinical

Active, not recruiting

Chronic Pelvic PainPhase 3

Active, not recruiting

AgingPreclinical

Completed

Hyaluronic AcidPreclinical

Not yet recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

309 competitors in COVID-19

#DrugCompanyPhaseTrials

Activella

Stivarga

Aimovig

Aldactone

Nexavar

Calciferol

Jazz Pharmaceuticals

Angiomax

BBaxter Healthcare Corporation

Tricor

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Benadryl

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Bone Health

NCT05704036

Post-ApprovalRecruiting

Overactive Bladder

NCT05221021

N/ANot yet recruiting

Stress Urinary Incontinence

NCT07186985

Q2 2028

Phase 1Recruiting

Aging

NCT06520982

Q4 2028

Phase 2Recruiting

Anorexia Nervosa

NCT03875378

Q2 2029

Phase 2Recruiting

Prostate Adenocarcinoma

NCT07466498

Clinical

Trials by Indication[1]

Estrogen6 trials

Estrogen Hormone Protocol

Completed·NNational Institute on Aging (NIA)·Phase 3·NCT00000177·120 enrolled

Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Unknown status·RRigshospitalet, Denmark·N/A·NCT05302726·20 enrolled

Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·N/A·NCT00004274·260 enrolled

Show 3 more trials

Estrogen and Serotonin on Changing Brain Chemistry

Completed·UUniversity of Colorado, Denver·N/A·NCT01208324·47 enrolled

The Effects of Aging and Estrogen on the Pituitary

Unknown status·MMassachusetts General Hospital·Phase 2/3·NCT00386022·19 enrolled

Postmenopausal Pessary Users: Estrogen Versus Trimosan

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03943823·4 enrolled

Postmenopausal Women3 trials

Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00001752·30 enrolled

Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Completed·PPeking Union Medical College Hospital·Phase 4·NCT01833663·200 enrolled

Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

Completed·—·Phase 3·NCT01501422·40 enrolled

MPA2 trials

Menopausal Hormones and Sympathetic Activation

Not yet recruiting·UUniversity of Delaware·Phase 4·NCT07420218·80 enrolled

Impact of Estradiol Addback

Completed·MMayo Clinic·Phase 1·NCT01862835·43 enrolled

Menopausal Women2 trials

Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women

Completed·MMayo Clinic·N/A·NCT00443716·60 enrolled

Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00029757·15 enrolled

Alzheimer's Disease2 trials

Alzheimer's Disease Prevention Trial

Completed·NNational Institute on Aging (NIA)·Phase 3·NCT00000176

Alzheimer's Disease and Aging: Therapeutic Potential of Estrogen

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018343

35 more indications

Aging2 trials

Early Neurovascular Adaptations in Aging Women

Recruiting·UUniversity of Missouri-Columbia·Phase 1·NCT06520982·64 enrolled

Metabolic Effects of Androgenicity in Aging Men and Women

Completed·VVA Office of Research and Development·N/A·NCT00680797·33 enrolled

Cognition2 trials

The Effects of Sex Hormones on Cognition and Mood in Older Adults

Terminated·NNational Institute on Aging (NIA)·N/A·NCT00000175

Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

Unknown status·NNational Center for Research Resources (NCRR)·Phase 2·NCT00005768

Prostate Cancer2 trials

Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy

Not yet recruiting·—·Phase 2·NCT06271551·310 enrolled

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00586898·36 enrolled

Female2 trials

Investigation of the Effect of the Female Urinary Microbiome on Incontinence

Completed·LLoyola University·Phase 4·NCT02835846·35 enrolled

Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women: A Single-Group Pre-Post Experimental Study

Active, not recruiting·KKhyber Medical University Peshawar·Preclinical·NCT07821086·30 enrolled

Overactive Bladder1 trial

Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

Recruiting·WWalter Reed National Military Medical Center·Phase 4·NCT05221021·152 enrolled

Drug1 trial

Coronary Drug Project

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000482

Depression1 trial

Estrogen and Perimenopausal Depression

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00229450·17 enrolled

Hormone Therapy1 trial

Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women

Completed·EEmory University··NCT04531943·285 enrolled

Atrophy1 trial

Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy

Completed·FFaculdade de Medicina do ABC·Phase 3·NCT02419729·45 enrolled

Turner syndrome1 trial

The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome

Completed·TThomas Jefferson University·Phase 3·NCT00029159·200 enrolled

Pregnancy1 trial

Pregnancy Outcome of Women Using Low Molecular Weight Heparin Before Frozen-thawed Embryo Transfer

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT03120715·342 enrolled

Adolescent1 trial

Bone Mass Accrual in Adolescent Athletes

Withdrawn·MMassachusetts General Hospital·Phase 3·NCT00827151

Mortality1 trial

Coronary Drug Project Mortality Surveillance

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·N/A·NCT00000483

Function1 trial

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Completed·WWashington University School of Medicine·N/A·NCT00805207·61 enrolled

Microcirculation1 trial

Chronic Effects of Estrogen in Microcirculation

Completed·RRio de Janeiro State University·Phase 4·NCT01295892·44 enrolled

Memory1 trial

Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00006399·45 enrolled

Hot flashes1 trial

Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00332553·150 enrolled

Physical Therapy1 trial

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

Terminated·PPamela Moalli·N/A·NCT01648751·21 enrolled

Anorexia Nervosa1 trial

Transdermal Estrogen in Women With Anorexia Nervosa

Recruiting·—·Phase 2·NCT03875378·66 enrolled

Metabolism1 trial

Regulation of Cortisol Metabolism and Fat Patterning

Unknown status·OOregon Health and Science University·N/A·NCT00694733·140 enrolled

Menopause1 trial

Bioenergetic Effects of Aging and Menopause (BEAM)

Unknown status·UUniversity of Colorado, Denver·Phase 4·NCT04043520·57 enrolled

Oxytocin1 trial

Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin

Completed·UUniversity Hospital, Bonn·Phase 1·NCT04330677·487 enrolled

Prevention1 trial

Methenamine in a Non-antibiotic, Multimodal Approach to UTI Prevention

Withdrawn·WWashington University School of Medicine·Phase 4·NCT03996057

Hyaluronic Acid1 trial

Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study

Not yet recruiting·NNYU Langone Health·N/A·NCT07038070·196 enrolled

Bone Health1 trial

Estrogen Supplementation and Bone Health in Women With CF

Recruiting·JJohns Hopkins University·Phase 4·NCT05704036·75 enrolled

Chronic Pelvic Pain1 trial

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Active, not recruiting·JJocelyn Fitzgerald·Phase 3·NCT05658874·26 enrolled

Primary Ovarian Insufficiency1 trial

Primary Ovarian Insufficiency: Phenotype and Optimal Treatment

Completed·—·Phase 3·NCT03568708·19 enrolled

Stress urinary incontinence1 trial

The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence

Not yet recruiting·HHanoi Medical University·N/A·NCT07186985·115 enrolled

Stroke1 trial

Women's Estrogen for Stroke Trial (WEST)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00026039

Progesterone1 trial

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism

Terminated·WWashington University School of Medicine·N/A·NCT00565916·22 enrolled

Prostate Adenocarcinoma1 trial

Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)

Recruiting·UUniversity of Washington·Phase 2·NCT07466498·60 enrolled

Premature ovarian insufficiency1 trial

Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency

Recruiting·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT06851754·185 enrolled

Pelvic Organ Prolapse1 trial

A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

Recruiting·QQueen's University·Phase 3·NCT07030426·180 enrolled

Vulvovaginal Atrophy1 trial

GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

Completed·UUniversity Hospital, Ghent·Approved·NCT05562518·31 enrolled

Unspecified3 trials

Clinical Study of in Situ Regeneration of Endometrium

Unknown status·YYali Hu·Phase 1/2·NCT04233892·345 enrolled

Estradiol Supplementation and Rotator Cuff Repair

Not yet recruiting·UUniversity of Utah·Phase 2·NCT06318403·58 enrolled

Effect of Estradiol Topical Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT05645393·4 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 18, 1998

ACTIVELLA

NDA NDA020907

Feb 10, 2000

ACTIVELLA

NDA NDA020907

Apr 11, 2000

ACTIVELLA

NDA NDA020907

Nov 14, 2000

ACTIVELLA

NDA NDA020907

Sep 13, 2002

ACTIVELLA

NDA NDA020907

Jul 26, 2004

ACTIVELLA

NDA NDA020907

Jun 30, 2005

ACTIVELLA

NDA NDA020907

Dec 28, 2006

ACTIVELLA

NDA NDA020907

Dec 28, 2006

ACTIVELLA

NDA NDA020907

Oct 8, 2013

ACTIVELLA

NDA NDA020907

Jan 12, 2015

ACTIVELLA

NDA NDA020907

May 27, 2016

ACTIVELLA

NDA NDA020907

Nov 1, 2017

ACTIVELLA

NDA NDA020907

Apr 6, 2020

ACTIVELLA

NDA NDA020907

Aug 10, 2021

ACTIVELLA

NDA NDA020907

Aug 10, 2021

ACTIVELLA

NDA NDA020907

Feb 15, 2024

ACTIVELLA

NDA NDA020907

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Estrogen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Activella drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Estrogen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Estrogen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020907). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Related News