Estrasorb

(estradiol valerate)

ApprovedSmall molecule

Estrasorb is a small molecule that works as a Estrogen Receptor Alpha Agonist.[2] It is being used across 15 indications, with its most advanced program in Approved.[1]

Estrasorb is one of 164 small molecule programs targeting Atrophy. It is currently in Approved.

Indications

Total Trials

Active Trials

163

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AtrophyUnknown

HypogonadismUnknown

Premature Ovarian InsufficiencyUnknown

Primary Ovarian InsufficiencyUnknown

MenorrhagiaUnknown

Female InfertilityActive, not recruiting

VolumeCompleted

Gnrh AntagonistCompleted

AVP DeficiencyRecruiting

EstrogenCompleted

AtrophyPreclinical

Unknown

HypogonadismPreclinical

Unknown

Premature Ovarian InsufficiencyPreclinical

Unknown

Primary Ovarian InsufficiencyPreclinical

Unknown

MenorrhagiaPreclinical

Unknown

Female InfertilityPreclinical

Active, not recruiting

VolumePreclinical

Completed

Gnrh AntagonistPreclinical

Completed

AVP DeficiencyPreclinical

Recruiting

EstrogenPreclinical

Completed

Showing 10 of 15 indications

Competition

Competitive Landscape

145 competitors in Efficacy

#DrugCompanyPhaseTrials

Estrasorb

Novo Nordisk

Approved

1 2

Oncovin

Eli Lilly

Phase 3

4 3

Tivicay

GSK

Phase 3

2 4

Rogaine

Pfizer

Phase 3

1 5

Rayos

RRoxane Laboratories

Phase 3

5 6

Paraplatin

AAvyxa

Phase 3

4 7

Alimta

SShawn Eagle

Phase 3

3 8

Cytoxan

BBaxter Healthcare Corporation

Phase 3

3 9

Lesinurad

EEsperion Therapeutics, Inc.

Phase 3

2 10

Insulin 320

Novo Nordisk

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Infertility, Female

NCT05473273

Q1 2027

PreclinicalRecruiting

AVP Deficiency

NCT07361263

Q1 2028

N/ARecruiting

Intrusive Memories

NCT07419594

Q4 2029

Phase 2Not yet recruiting

Turner Syndrome

NCT07041814

Clinical

Trials by Indication[1]

Endometrial3 trials

HRT Versus MOS for Endometrial Preparation Prior to FET in PCOS Patients

Completed·MMansoura University··NCT02273791·126 enrolled

HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients

Unknown status·MMansoura University·Phase 4·NCT02330757·150 enrolled

Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium

Unknown status·—·Phase 1·NCT04283435·100 enrolled

Frozen Embryo Transfer3 trials

Sildenafil Citrate in Frozen Embryo Transfer

Completed·OOmar Ahmed El Sayed Saad·Phase 2·NCT02845388·90 enrolled

Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles

Completed·—·N/A·NCT05189145·600 enrolled

The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer

Completed·RRahem Fertility Center·Phase 4·NCT04507022·112 enrolled

Treatment3 trials

Pretreatment With Estradiol Valerate

Completed·UUniversitair Ziekenhuis Brussel·Phase 4·NCT01218386·80 enrolled

Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

Completed·—·Phase 4·NCT05197374·114 enrolled

Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

Completed·MMeir Medical Center·Phase 4·NCT01419353·63 enrolled

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

Embryo Transfer2 trials

Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer

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

Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles

Unknown status·—·N/A·NCT03854175·80 enrolled

22 more indications

Outcome2 trials

The Effect of Tamoxifen on Clinical Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.

Unknown status·SSun Yat-sen University·Phase 4·NCT03060304·100 enrolled

The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

Unknown status·ZZekai Tahir Burak Women's Health Research and Education Hospital·N/A·NCT02114645·100 enrolled

In Vitro Fertilization2 trials

Oestradiol Supplementation in Luteal Long Agonist Fresh In Vitro Fertilization/Intra Cytoplasmic Sperm Injection ( IVF/ICSI) Cycle .

Unknown status·—·Phase 3·NCT03832894·2 enrolled

Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

Unknown status·—·Phase 3·NCT03788681·170 enrolled

Stress1 trial

Estradiol and Stress Reactivity in Women

Recruiting·IInternational Research Training Group 2804··NCT06204016·74 enrolled

Polycystic Ovary Syndrome1 trial

Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

Withdrawn·CCRG UZ Brussel·Phase 4·NCT04002635

Oral1 trial

Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

Completed·IIVI Madrid·Phase 4·NCT01501448·118 enrolled

Ovulation Induction1 trial

Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Completed·—·Phase 4·NCT02352597·150 enrolled

Postmenopausal Osteoporosis1 trial

A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women

Completed·PPeking Union Medical College·Phase 4·NCT00860964·221 enrolled

Intrusive Memories1 trial

Estradiol and Intrusive Memories

Recruiting·—·N/A·NCT07419594·273 enrolled

Estrogen1 trial

Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women

Completed·UUniversity of Sao Paulo General Hospital·N/A·NCT01120665·62 enrolled

Effectiveness1 trial

Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

Completed·RReproductive & Genetic Hospital of CITIC-Xiangya·N/A·NCT03300518·552 enrolled

Efficacy1 trial

Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

Unknown status·—·N/A·NCT03329898·200 enrolled

Turner syndrome1 trial

A Study Comparing Different Treatment Approaches for the Initiation of Puberty in Girls With Turner Syndrome Using a TRIFECTA-DARED Approach for Rare Diseases

Not yet recruiting·UUniversiti Kebangsaan Malaysia Medical Centre·Phase 2·NCT07041814·24 enrolled

ART1 trial

Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Completed·FFederal University of Minas Gerais·N/A·NCT02161614·60 enrolled

Atrophic Vaginitis1 trial

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

Terminated·MMaire Mac Bride·Phase 3·NCT00816556·63 enrolled

CLE1 trial

Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

Terminated·SSt. Louis University··NCT04551144·4 enrolled

Prevention1 trial

Estrogen in the Prevention of Adhesion Reformation

Unknown status·—·Phase 4·NCT03620929·186 enrolled

Volume1 trial

Estradiol's Effect on Brain Volume and Connectivity

Completed·IInternational Research Training Group 2804·N/A·NCT06312033·32 enrolled

AVP Deficiency1 trial

Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP-Deficiency

Recruiting·UUniversity Hospital, Basel, Switzerland·Preclinical·NCT07361263·28 enrolled

GnRH Antagonist1 trial

Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol: A Randomized Clinical Trial

Completed·CCairo University·Preclinical·NCT07727863·61 enrolled

Infertility1 trial

Optimal Timing of Euploid Day 6 Blastocyst (Blastocyst Which Was Biopsied on Day 6 After Fertilization) Transfer in Frozen Hormonal Replacement Therapy Cycles: Day 6 or Day 7 of Progesterone Administration?

Suspended·AART Fertility Clinics LLC·Phase 1·NCT05980091·316 enrolled

Infertility, Female1 trial

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle (NC).

Recruiting·AART Fertility Clinics LLC··NCT05473273·40 enrolled

Unspecified1 trial

Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium

Completed· Bayer logo

Bayer·Phase 1·NCT01031355·42 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DELESTROGEN

NDA NDA009402

Sep 10, 1986

ESTRADERM

NDA NDA019081

Apr 26, 1996

ESTRING

NDA NDA020472

Dec 3, 1996

FEMPATCH

NDA NDA020417

Aug 4, 1998

ESCLIM

NDA NDA020847

Mar 5, 1999

CLIMARA

NDA NDA020375

Sep 20, 1999

ESTRADIOL

NDA NDA021048

Aug 16, 2000

VIVELLE

NDA NDA020323

Apr 5, 2002

ALORA

NDA NDA020655

May 3, 2002

VIVELLE-DOT

NDA NDA020538

Mar 20, 2003

FEMRING

NDA NDA021367

Oct 9, 2003

ESTRASORB

NDA NDA021371

Feb 9, 2004

ESTROGEL

NDA NDA021166

Jun 8, 2004

MENOSTAR

NDA NDA021674

Aug 20, 2004

FEMTRACE

NDA NDA021633

Dec 15, 2006

ELESTRIN

NDA NDA021813

Jun 4, 2007

DIVIGEL

NDA NDA022038

Jul 27, 2007

EVAMIST

NDA NDA022014

Nov 25, 2009

VAGIFEM

NDA NDA020908

Sep 23, 2014

MINIVELLE

NDA NDA203752

May 29, 2018

IMVEXXY

NDA NDA208564

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for estradiol valerate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — estradiol valerate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for estradiol valerate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208564). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novo Nordisk company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novo Nordisk

Estrasorb

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2028

Q4 2029

Trials by Indication[1]

Endometrial3 trials

Frozen Embryo Transfer3 trials

Treatment3 trials

Hormone Replacement Therapy2 trials

Embryo Transfer2 trials

Outcome2 trials

In Vitro Fertilization2 trials

Stress1 trial

Polycystic Ovary Syndrome1 trial

Oral1 trial

Ovulation Induction1 trial

Postmenopausal Osteoporosis1 trial

Intrusive Memories1 trial

Estrogen1 trial

Effectiveness1 trial

Efficacy1 trial

Turner syndrome1 trial

ART1 trial

Atrophic Vaginitis1 trial

CLE1 trial

Prevention1 trial

Volume1 trial

AVP Deficiency1 trial

GnRH Antagonist1 trial

Infertility1 trial

Infertility, Female1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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