Lupron

Phase 2Small molecule

Lupron is one of 23 small molecule programs targeting Allogeneic Hematopoietic Stem Cell Transplantation. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

181

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Allogeneic Hematopoietic Stem Cell TransplantationActive, not recruiting

Allogeneic Hematopoietic Stem Cell TransplantationPhase 2

Active, not recruiting

Competition

Competitive Landscape

23 competitors in Allogeneic Hematopoietic Stem Cell Transplantation

#DrugCompanyPhaseTrials

Venclexta

AbbVie

Phase 3

2 2

Dacogen

Sun Pharmaceutical Industries, Inc.

Phase 3

1 3

Nexavar

Bayer

Phase 3

1 4

Fludara

Sanofi

Phase 2

10 5

Cellcept

Roche

Phase 2

4 6

Tepadina

Jazz Pharmaceuticals

Phase 2

2 7

Cytoxan

BBaxter Healthcare Corporation

Phase 2

8 8

Mesenchymal Stromal Cells

Mario Negri Institute for Pharmacological Research

Phase 3

1 9

Alkeran

AApotex Inc.

Phase 2

4 10

Busulfex

Akero Therapeutics

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Allogeneic Hematopoietic Stem Cell Transplantation

NCT01746849

Q2 2031

Phase 2Recruiting

Prostate Cancer

NCT07027124

Clinical

Trials by Indication[1]

Prostate Cancer6 trials

A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT03572387·14 enrolled

Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Terminated·—·Phase 3·NCT00243646·6 enrolled

Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Terminated·PPharmatech·Phase 4·NCT02749825·41 enrolled

Show 3 more trials

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00002597·2,028 enrolled

Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04331717

Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT07027124·40 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01746849·82 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 26, 1989

LUPRON DEPOT

NDA NDA019732

Oct 22, 1990

LUPRON DEPOT

NDA NDA020011

Dec 14, 1990

LUPRON DEPOT

NDA NDA019732

Mar 26, 1992

LUPRON DEPOT

NDA NDA019732

Jan 21, 1994

LUPRON DEPOT-PED KIT

NDA NDA020263

Feb 14, 1994

LUPRON DEPOT

NDA NDA019732

Feb 14, 1994

LUPRON DEPOT

NDA NDA020011

Feb 14, 1994

LUPRON DEPOT-PED KIT

NDA NDA020263

Apr 26, 1994

LUPRON DEPOT

NDA NDA019732

Apr 26, 1994

LUPRON DEPOT

NDA NDA020011

Jul 21, 1994

LUPRON DEPOT

NDA NDA020011

Nov 7, 1994

LUPRON DEPOT

NDA NDA020011

Nov 7, 1994

LUPRON DEPOT-PED KIT

NDA NDA020263

Nov 8, 1994

LUPRON DEPOT

NDA NDA019732

Mar 24, 1995

LUPRON DEPOT-PED KIT

NDA NDA020263

Aug 11, 1995

LUPRON DEPOT

NDA NDA020011

Aug 11, 1995

LUPRON DEPOT-PED KIT

NDA NDA020263

Aug 11, 1995

LUPRON DEPOT

NDA NDA019732

Sep 22, 1995

LUPRON DEPOT

NDA NDA020011

Sep 22, 1995

LUPRON DEPOT-PED KIT

NDA NDA020263

Sep 22, 1995

LUPRON DEPOT

NDA NDA019732

Oct 26, 1995

LUPRON DEPOT

NDA NDA020011

Oct 26, 1995

LUPRON DEPOT-PED KIT

NDA NDA020263

Oct 26, 1995

LUPRON DEPOT

NDA NDA019732

Sep 12, 1996

LUPRON DEPOT

NDA NDA020011

Dec 3, 1996

LUPRON DEPOT

NDA NDA020517

Jan 10, 1997

LUPRON DEPOT-PED KIT

NDA NDA020263

May 30, 1997

LUPRON DEPOT

NDA NDA020517

Jun 27, 1997

LUPRON DEPOT

NDA NDA019732

Jun 27, 1997

LUPRON DEPOT

NDA NDA020011

Jun 27, 1997

LUPRON DEPOT-PED KIT

NDA NDA020263

Sep 4, 1997

LUPRON DEPOT

NDA NDA020708

Dec 23, 1997

LUPRON DEPOT

NDA NDA020708

Dec 23, 1997

LUPRON DEPOT

NDA NDA020517

Jan 9, 1998

LUPRON DEPOT

NDA NDA019732

Apr 9, 1998

LUPRON DEPOT

NDA NDA020011

Apr 9, 1998

LUPRON DEPOT

NDA NDA020708

Jun 30, 1998

LUPRON DEPOT

NDA NDA020011

Jun 30, 1998

LUPRON DEPOT

NDA NDA019732

Jun 30, 1998

LUPRON DEPOT-PED KIT

NDA NDA020263

Jul 29, 1998

LUPRON DEPOT

NDA NDA020708

Jul 29, 1998

LUPRON DEPOT

NDA NDA020517

Feb 11, 1999

LUPRON DEPOT

NDA NDA020708

Aug 13, 1999

LUPRON DEPOT

NDA NDA019732

Aug 13, 1999

LUPRON DEPOT-PED KIT

NDA NDA020263

Aug 13, 1999

LUPRON DEPOT

NDA NDA020517

Aug 13, 1999

LUPRON DEPOT

NDA NDA020011

Aug 13, 1999

LUPRON DEPOT

NDA NDA020708

Oct 4, 1999

LUPRON DEPOT

NDA NDA019732

May 11, 2000

LUPRON DEPOT-PED KIT

NDA NDA020263

May 11, 2000

LUPRON DEPOT

NDA NDA020517

May 11, 2000

LUPRON DEPOT

NDA NDA020011

May 11, 2000

LUPRON DEPOT

NDA NDA019732

May 11, 2000

LUPRON DEPOT

NDA NDA020708

May 12, 2000

LUPRON DEPOT-PED KIT

NDA NDA020263

May 12, 2000

LUPRON DEPOT

NDA NDA019732

May 12, 2000

LUPRON DEPOT

NDA NDA020517

May 12, 2000

LUPRON DEPOT

NDA NDA020708

May 12, 2000

LUPRON DEPOT

NDA NDA020011

Jan 24, 2001

LUPRON DEPOT

NDA NDA019732

Jan 24, 2001

LUPRON DEPOT

NDA NDA020517

Jan 24, 2001

LUPRON DEPOT

NDA NDA020011

Jan 24, 2001

LUPRON DEPOT

NDA NDA020708

Jan 26, 2001

LUPRON DEPOT-PED KIT

NDA NDA020263

Mar 1, 2001

LUPRON DEPOT

NDA NDA020011

Mar 1, 2001

LUPRON DEPOT

NDA NDA019732

Mar 1, 2001

LUPRON DEPOT

NDA NDA020517

Mar 1, 2001

LUPRON DEPOT

NDA NDA020708

Jul 23, 2001

LUPRON DEPOT

NDA NDA020517

Jul 23, 2001

LUPRON DEPOT

NDA NDA020708

Aug 6, 2001

LUPRON DEPOT-PED KIT

NDA NDA020263

Sep 21, 2001

LUPRON DEPOT

NDA NDA020011

Sep 21, 2001

LUPRON DEPOT

NDA NDA020708

Nov 14, 2001

LUPRON DEPOT

NDA NDA020708

Nov 14, 2001

LUPRON DEPOT

NDA NDA020011

Feb 21, 2002

LUPRON DEPOT

NDA NDA020011

Feb 21, 2002

LUPRON DEPOT

NDA NDA019732

Mar 8, 2002

LUPRON DEPOT-PED KIT

NDA NDA020263

May 16, 2002

LUPRON DEPOT-PED KIT

NDA NDA020263

May 23, 2002

LUPRON DEPOT

NDA NDA019732

May 23, 2002

LUPRON DEPOT

NDA NDA020011

May 23, 2002

LUPRON DEPOT

NDA NDA020708

May 23, 2002

LUPRON DEPOT

NDA NDA020517

Sep 20, 2002

LUPRON DEPOT

NDA NDA020708

Sep 20, 2002

LUPRON DEPOT

NDA NDA019732

Sep 20, 2002

LUPRON DEPOT

NDA NDA020517

Sep 20, 2002

LUPRON DEPOT

NDA NDA020011

Sep 24, 2002

LUPRON DEPOT-PED KIT

NDA NDA020263

Sep 9, 2003

LUPRON DEPOT

NDA NDA019732

Sep 9, 2003

LUPRON DEPOT

NDA NDA020517

Oct 28, 2003

LUPRON DEPOT-PED KIT

NDA NDA020263

Dec 23, 2003

LUPRON DEPOT-PED KIT

NDA NDA020263

Jan 12, 2004

LUPRON DEPOT

NDA NDA019732

Jan 12, 2004

LUPRON DEPOT

NDA NDA020708

Jan 12, 2004

LUPRON DEPOT

NDA NDA020011

Jan 12, 2004

LUPRON DEPOT

NDA NDA020517

Jan 15, 2004

LUPRON DEPOT

NDA NDA020011

Jan 15, 2004

LUPRON DEPOT

NDA NDA020708

Mar 2, 2004

LUPRON DEPOT-PED KIT

NDA NDA020263

Sep 15, 2005

LUPRON DEPOT

NDA NDA020011

Sep 15, 2005

LUPRON DEPOT

NDA NDA020011

Sep 15, 2005

LUPRON DEPOT

NDA NDA019732

Sep 15, 2005

LUPRON DEPOT

NDA NDA020708

Sep 15, 2005

LUPRON DEPOT

NDA NDA020517

Sep 15, 2005

LUPRON DEPOT

NDA NDA020708

Sep 15, 2005

LUPRON DEPOT

NDA NDA019732

Sep 15, 2005

LUPRON DEPOT

NDA NDA020517

Nov 9, 2005

LUPRON DEPOT-PED KIT

NDA NDA020263

Feb 16, 2006

LUPRON DEPOT-PED KIT

NDA NDA020263

Oct 31, 2007

LUPRON DEPOT

NDA NDA020708

Oct 31, 2007

LUPRON DEPOT

NDA NDA020011

Jul 31, 2008

LUPRON DEPOT-PED KIT

NDA NDA020263

Jun 2, 2009

LUPRON DEPOT

NDA NDA020708

Jun 2, 2009

LUPRON DEPOT

NDA NDA020011

Jun 24, 2009

LUPRON DEPOT-PED KIT

NDA NDA020263

Apr 28, 2010

LUPRON DEPOT

NDA NDA020517

Apr 28, 2010

LUPRON DEPOT

NDA NDA019732

Apr 28, 2010

LUPRON DEPOT

NDA NDA020517

Apr 28, 2010

LUPRON DEPOT

NDA NDA019732

Apr 28, 2010

LUPRON DEPOT

NDA NDA019732

Apr 28, 2010

LUPRON DEPOT

NDA NDA020517

Aug 30, 2010

LUPRON DEPOT-PED KIT

NDA NDA020263

Oct 29, 2010

LUPRON DEPOT

NDA NDA020708

Oct 29, 2010

LUPRON DEPOT

NDA NDA020011

Jan 14, 2011

LUPRON DEPOT

NDA NDA019732

Jan 14, 2011

LUPRON DEPOT

NDA NDA020517

Jun 14, 2011

LUPRON DEPOT

NDA NDA020011

Jun 14, 2011

LUPRON DEPOT

NDA NDA020708

Jun 17, 2011

LUPRON DEPOT

NDA NDA020517

Jun 17, 2011

LUPRON DEPOT

NDA NDA020517

Jun 17, 2011

LUPRON DEPOT

NDA NDA020517

Aug 15, 2011

LUPRON DEPOT-PED KIT

NDA NDA020263

Oct 8, 2011

LUPRON DEPOT-PED KIT

NDA NDA020263

Jan 23, 2012

LUPRON DEPOT

NDA NDA020708

Jan 23, 2012

LUPRON DEPOT

NDA NDA020011

Feb 17, 2012

LUPRON DEPOT

NDA NDA019732

Mar 28, 2012

LUPRON DEPOT

NDA NDA020708

Mar 28, 2012

LUPRON DEPOT

NDA NDA020011

Jul 18, 2012

LUPRON DEPOT

NDA NDA020517

May 14, 2013

LUPRON DEPOT-PED KIT

NDA NDA020263

Jul 10, 2013

LUPRON DEPOT

NDA NDA020517

Jul 10, 2013

LUPRON DEPOT

NDA NDA019732

Oct 30, 2013

LUPRON DEPOT

NDA NDA020011

Oct 30, 2013

LUPRON DEPOT

NDA NDA020708

Nov 8, 2013

LUPRON DEPOT

NDA NDA020517

Jun 27, 2014

LUPRON DEPOT

NDA NDA020517

Jun 27, 2014

LUPRON DEPOT

NDA NDA019732

Feb 11, 2016

LUPRON DEPOT

NDA NDA020517

Jun 6, 2016

LUPRON DEPOT

NDA NDA019732

Jun 6, 2016

LUPRON DEPOT

NDA NDA020517

May 19, 2017

LUPRON DEPOT-PED KIT

NDA NDA020263

Apr 18, 2018

LUPRON DEPOT

NDA NDA020708

Dec 10, 2018

LUPRON DEPOT

NDA NDA020517

Dec 10, 2018

LUPRON DEPOT

NDA NDA019732

Mar 4, 2019

LUPRON DEPOT

NDA NDA019732

Mar 4, 2019

LUPRON DEPOT

NDA NDA020517

Mar 18, 2020

LUPRON DEPOT

NDA NDA020708

Apr 7, 2020

LUPRON DEPOT-PED KIT

NDA NDA020263

Feb 12, 2021

LUPRON DEPOT

NDA NDA020011

Mar 11, 2021

LUPRON DEPOT-PED KIT

NDA NDA020263

Mar 11, 2021

LUPRON DEPOT-PED KIT

NDA NDA020263

Nov 12, 2021

LUPRON DEPOT-PED KIT

NDA NDA020263

Apr 18, 2022

LUPRON DEPOT

NDA NDA020517

Apr 18, 2022

LUPRON DEPOT

NDA NDA019732

Apr 22, 2022

LUPRON DEPOT-PED KIT

NDA NDA020263

Jan 27, 2023

LUPRON DEPOT

NDA NDA020011

Apr 14, 2023

LUPRON DEPOT-PED KIT

NDA NDA020263

Dec 4, 2023

LUPRON DEPOT

NDA NDA020517

Dec 4, 2023

LUPRON DEPOT

NDA NDA019732

Dec 4, 2023

LUPRON DEPOT-PED KIT

NDA NDA020263

Mar 21, 2024

LUPRON DEPOT

NDA NDA019732

Mar 21, 2024

LUPRON DEPOT

NDA NDA020517

May 22, 2025

LUPRON DEPOT-PED KIT

NDA NDA020263

Aug 18, 2025

LUPRON DEPOT

NDA NDA019732

Aug 18, 2025

LUPRON DEPOT

NDA NDA020517

Sep 10, 2025

LUPRON DEPOT

NDA NDA020011

Sep 10, 2025

LUPRON DEPOT

NDA NDA020708

Sep 10, 2025

LUPRON DEPOT

NDA NDA020708

Sep 10, 2025

LUPRON DEPOT

NDA NDA020011

Sep 23, 2025

LUPRON DEPOT-PED KIT

NDA NDA020263

Nov 14, 2025

LUPRON DEPOT-PED KIT

NDA NDA020263

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Lupron. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lupron compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lupron. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020263). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Radiation Therapy Oncology Group company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Radiation Therapy Oncology Group

Lupron

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2031

Trials by Indication[1]

Prostate Cancer6 trials

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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