Myelodysplastic Syndrome (MDS)

Oncology
7
Pipeline Programs
6
Companies
7
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
4
0
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 5 programs with unclassified modality

On Market (1)

Approved therapies currently available

Amgen
ARANESPApproved
darbepoetin alfa
Amgen
Erythropoiesis-stimulating Agent [EPC]subcutaneous2001

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
1
Darbepoetin AlfaPhase 31 trial
Active Trials
NCT02175277Completed9Est. Mar 2017
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
PF-04449913Phase 21 trial
lintuzumabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT00502112Completed13Est. May 2010
NCT01842646Completed35Est. Jun 2021
Novartis
NovartisBASEL, Switzerland
2 programs
2
MBG453Phase 21 trial
sabatolimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT04878432Terminated39Est. Sep 2024
NCT04812548Terminated20Est. May 2023
FUJIFILM Pharma
FUJIFILM PharmaMA - Cambridge
1 program
1
FF-10501-01Phase 21 trial
Active Trials
NCT03486353WithdrawnEst. Oct 2019
Providence Therapeutics
1 program
MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue BankN/A1 trial
Active Trials
NCT02537990UnknownEst. Feb 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AmgenDarbepoetin Alfa
NovartisMBG453
Novartissabatolimab
FUJIFILM PharmaFF-10501-01
PfizerPF-04449913
Pfizerlintuzumab
Providence TherapeuticsMDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank

Clinical Trials (7)

Total enrollment: 116 patients across 7 trials

NCT02175277AmgenDarbepoetin Alfa

Darbepoetin Alfa MDS Companion Protocol

Start: Jun 2014Est. completion: Mar 20179 patients
Phase 3Completed
NCT04878432NovartisMBG453

STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

Start: Mar 2022Est. completion: Sep 202439 patients
Phase 2Terminated
NCT04812548Novartissabatolimab

A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants

Start: May 2021Est. completion: May 202320 patients
Phase 2Terminated
NCT03486353FUJIFILM PharmaFF-10501-01

A Study of FF-10501-01 in Combination with Azacitidine in Patients with Myelodysplastic Syndrome

Start: Oct 2019Est. completion: Oct 2019
Phase 2Withdrawn
NCT01842646PfizerPF-04449913

Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS)

Start: Aug 2013Est. completion: Jun 202135 patients
Phase 2Completed
NCT00502112Pfizerlintuzumab

A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

Start: Mar 2008Est. completion: May 201013 patients
Phase 1Completed
NCT02537990Providence TherapeuticsMDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank

MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank

Start: Aug 2005Est. completion: Feb 2020
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
6 companies competing in this space

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