NCT00514813
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Diabetes Mellitus · Hemophilia A
Takeda
Takeda is a pharma organization headquartered in Cambridge, USA. Primary therapeutic focus areas include Diabetes Mellitus, Hemophilia A, Crohn's Disease, Hypertension, Type 2 Diabetes Mellitus. NovaPharmaNews links 1179
Cambridge, USA HQ
1993 Founded
1,617 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- Cambridge, USA
- Founded
- 1993
- Employees
- 1,617
- Programs
- 1179
- Drugs
- 359
- Patents
- 1436
Dynepo
Approved · small molecule · Anemia
Dynepo (epoetin delta) is a small-molecule erythropoiesis-stimulating agent developed by Takeda for the treatment of anemia. The drug was approved in the European Union on 29 February 2008 under marketing authorization holder Shire Pharmaceutical Contracts Limited (EMEA/H/C/000372). However, the program was terminated
Internal code SPD490-402
At a glance
- Sponsor
- Takeda
- Phase
- Approved
- Modality
- small_molecule
- Indication
- Anemia
- Status
- terminated
- Trials
- 1
Executive summary
Dynepo (epoetin delta) is a small-molecule erythropoiesis-stimulating agent developed by Takeda for the treatment of anemia. The drug was approved in the European Union on 29 February 2008 under marketing authorization holder Shire Pharmaceutical Contracts Limited (EMEA/H/C/000372). However, the program was terminated and the EU marketing authorization was subsequently withdrawn. As of the latest milestone dated 13 July 2021, Dynepo is no longer in active development. The drug represented Takeda's entry into the competitive erythropoiesis-stimulating protein market, which includes multiple approved therapies from competitors including Amgen, Hoffmann-La Roche, Teva, and others. The termination reflects either commercial underperformance or strategic deprioritization within Takeda's anemia portfolio, which includes other approved agents such as Feraheme and Omontys.
Why this program matters
Anemia remains a significant clinical burden affecting millions of patients globally, particularly those with chronic kidney disease, cancer, and other chronic conditions. The erythropoiesis-stimulating agent market is highly competitive and mature, with multiple established therapies commanding substantial market share. Dynepo's withdrawal from the EU market indicates that despite regulatory approval, the product failed to achieve meaningful commercial traction or clinical differentiation versus established competitors. The competitive landscape includes long-acting agents (Mircera, Aranesp), biosimilars (Retacrit), and newer mechanisms such as hypoxia-inducible factor stabilizers (Evrenzo) and luspatercept (Reblozyl). Dynepo's termination underscores the challenges of competing in a crowded anemia therapeutics space where efficacy, safety profile, dosing convenience, and cost are critical differentiators. For Takeda, the decision to withdraw Dynepo likely reflects resource allocation toward higher-priority programs or stronger-performing assets within its hematology franchise. The program's failure provides insight into market dynamics and the difficulty of sustaining market position in mature therapeutic categories without clear clinical or commercial advantages.
Drug intelligence
Drug Class: Erythropoiesis-stimulating agent (ESA)
Modality: Small molecule
Active Ingredient: Epoetin delta
Brand Name: Dynepo
Therapeutic Classification: Blood and blood-forming organs (ATC B03)
Route of Administration: Not yet disclosed
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Related Therapies: Epoetin alfa (Eprex/Procrit), epoetin beta (NeoRecormon), darbepoetin alfa (Aranesp), methoxy polyethylene glycol-epoetin beta (Mircera), epoetin theta (Eprex Multidose), epoetin zeta (Retacrit)
First Approval: European Union, 29 February 2008
Patent Status: Not yet disclosed
anemia
Also known as: anaemia (disease), anemia (disease)
Overview
A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells. Clinically, anemia represents a reduction in the oxygen-transporting capacity of a designated volume of blood, resulting from an imbalance between blood loss (through hemorrhage or hemolysis) and blood production. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.
Treatment landscape
ClinicalTrials.gov lists 98 registered studies for Anaemia, (AACT aggregate).
Phase breakdown: NA (35), PHASE3 (21), PHASE1 (18), PHASE2 (12), PHASE4 (11), PHASE2/PHASE3 (1)
Common investigational therapies:
- GSK1278863
- Daprodustat
- Placebo
- rhEPO
- GSK1278863A
- Darbepoetin alfa
- Iron therapy
- Daprodustat (GSK1278863)
- Ferinject ® (Ferric carboxymaltose)
- Normal saline (0.9%)
Disease data sourced from MONDO Disease Ontology (MONDO:0002280), NCT00466297, NCT00767702, NCT01043133, NCT01317979, NCT01477281, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, NCT00140517, NCT00238043, NCT00258024, NCT00259142, NCT00276224, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Approved2008-02-29
EU Marketing Authorization Granted
Dynepo received European Union marketing authorization as EMEA/H/C/000372 under marketing authorization holder Shire Pharmaceutical Contracts Limited.
- Approved2021-07-13
Program Terminated / Withdrawn
As of the latest milestone, Dynepo program was terminated and the EU marketing authorization was withdrawn.
Competitive landscape
Dynepo competed in a mature and highly fragmented erythropoiesis-stimulating agent market dominated by established players. Hoffmann-La Roche markets two approved ESAs: Neorecormon (epoetin beta) and Mircera (methoxy polyethylene glycol-epoetin beta), the latter offering extended dosing intervals. Amgen's Aranesp (darbepoetin alfa) is a long-acting ESA with significant global market penetration. Teva Pharma GmbH markets Eporatio, and biosimilar competition emerged with Retacrit (epoetin zeta biosimilar). Takeda itself markets Feraheme (ferumoxytol) and Omontys (peginesatide), representing alternative mechanisms for anemia management. Newer-generation therapies including Evrenzo (roxadustat, a hypoxia-inducible factor stabilizer) and Reblozyl (luspatercept, an erythroid maturation agent) represent mechanistic alternatives that may offer advantages in specific patient populations. The competitive intensity, combined with safety concerns historically associated with ESAs (thromboembolic events, hypertension), likely contributed to Dynepo's inability to establish a sustainable market position. The withdrawal suggests Dynepo lacked sufficient clinical differentiation or commercial appeal relative to entrenched competitors and emerging alternatives.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| FERAHEME | Takeda | — | approved |
| OMONTYS | Takeda | — | approved |
| EPORATIO | Teva Pharma GmbH | — | approved |
| EPOSTIM | — | — | approved |
| JESDUVROQ | — | — | approved |
| FERACCRU | — | — | approved |
| ARANESP | Amgen | — | approved |
| MIRCERA | Hoffmann-La Roche | — | approved |
| NEORECORMON | Hoffmann-La Roche | — | approved |
| EVRENZO | — | — | approved |
| REBLOZYL | — | — | approved |
| RETACRIT | — | — | approved |
| VOXELOTOR | — | Hemoglobin HbA positive modulator | Approved |
| TRIAMCINOLONE ACETONIDE | — | Glucocorticoid receptor agonist | Approved |
| SUTIMLIMAB | — | Complement C1s inhibitor | Approved |
| RUXOLITINIB PHOSPHATE | — | Tyrosine-protein kinase JAK2 inhibitor | Approved |
| RAVULIZUMAB | — | Complement C5 inhibitor | Approved |
| PREDNISONE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE SODIUM PHOSPHATE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE ACETATE | — | Glucocorticoid receptor agonist | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
European Union: Dynepo received marketing authorization on 29 February 2008 under EMEA/H/C/000372, with Shire Pharmaceutical Contracts Limited as the marketing authorization holder. The authorization was subsequently withdrawn; the exact date of withdrawal is not yet disclosed, but the program was terminated by the latest milestone of 13 July 2021.
United States (FDA): Regulatory status not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
China (NMPA): Regulatory status not yet disclosed.
Other Markets: Regulatory status in additional jurisdictions not yet disclosed.
Clinical evidence summary
Key questions answered
What is Dynepo used for?
Dynepo (epoetin delta) is an erythropoiesis-stimulating agent indicated for the treatment of anemia, typically in patients with chronic kidney disease or cancer-related anemia.
Is Dynepo currently approved?
Dynepo received European Union marketing authorization on 29 February 2008, but the authorization was subsequently withdrawn. The program was terminated as of July 2021, and the drug is no longer marketed.
Who developed Dynepo?
Dynepo was developed by Takeda. The original marketing authorization holder in the EU was Shire Pharmaceutical Contracts Limited.
What is the active ingredient in Dynepo?
The active ingredient in Dynepo is epoetin delta, a recombinant erythropoietin analog.
How does Dynepo work?
The specific mechanism of action for Dynepo is not yet disclosed, but as an erythropoiesis-stimulating agent, it is presumed to stimulate red blood cell production by binding to erythropoietin receptors.
What is the route of administration for Dynepo?
The route of administration for Dynepo is not yet disclosed.
Why was Dynepo withdrawn from the market?
The specific reason for Dynepo's withdrawal is not yet disclosed, but likely reflects commercial underperformance or strategic deprioritization by Takeda in a highly competitive ESA market.
What clinical trials supported Dynepo's approval?
One clinical trial (NCT00514813) is associated with Dynepo's development, but detailed trial objectives, design, and results are not yet disclosed.
What are the main competitors to Dynepo?
Competitors include Aranesp (Amgen), Mircera and Neorecormon (Hoffmann-La Roche), Eporatio (Teva), Retacrit (biosimilar), and newer agents such as Evrenzo and Reblozyl.
Is Dynepo approved in the United States?
U.S. regulatory status for Dynepo is not yet disclosed.
What is the therapeutic class of Dynepo?
Dynepo is classified under ATC code B03 (Blood and blood-forming organs) as an erythropoiesis-stimulating agent.
When was Dynepo first approved?
Dynepo received its first regulatory approval in the European Union on 29 February 2008.
Is Dynepo a biosimilar?
No, Dynepo is not a biosimilar; it is an original erythropoietin analog developed by Takeda.
What is the patent status of Dynepo?
Patent status information for Dynepo is not yet disclosed.
Does Takeda have other anemia treatments?
Yes, Takeda markets Feraheme (ferumoxytol) and Omontys (peginesatide) for anemia treatment, representing alternative mechanisms to erythropoiesis-stimulating agents.
What is the current development status of Dynepo?
Dynepo development is terminated, the EU marketing authorization has been withdrawn, and the program is no longer active as of July 2021.
Entity relationship graph
Dynepo → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Analyst insights
Strategic Implications: Dynepo's termination reflects Takeda's strategic decision to exit or deprioritize a mature, highly competitive therapeutic category. The withdrawal occurred despite EU regulatory approval, indicating that approval alone was insufficient to sustain commercial viability. This decision aligns with industry trends toward portfolio rationalization and focus on higher-value therapeutic areas or products with clearer competitive differentiation.
Competitive Implications: The failure of Dynepo underscores the difficulty of competing in the ESA market without clear clinical advantages. Established competitors (Roche, Amgen) benefit from brand recognition, established clinical evidence, and healthcare provider relationships. Newer mechanisms (HIF stabilizers, luspatercept) are capturing market share by offering alternative efficacy/safety profiles. Biosimilar competition has further commoditized the ESA category, eroding pricing power.
Market Dynamics: The ESA market has contracted due to safety concerns (cardiovascular events, hypertension), increased scrutiny of off-label use, and reimbursement pressures. Dynepo's withdrawal suggests the market may not support multiple branded ESA products, particularly those without clear differentiation.
Future Catalysts: No active development milestones are expected for Dynepo. The program is terminated and unlikely to be revived.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is Dynepo?
- Dynepo is epoetin delta, an erythropoiesis-stimulating agent for anemia treatment.
- Who makes Dynepo?
- Takeda developed Dynepo; Shire Pharmaceutical Contracts Limited was the EU marketing authorization holder.
- What is Dynepo's indication?
- Anemia, typically in chronic kidney disease or cancer-related settings.
- Is Dynepo approved?
- Dynepo received EU approval on 29 February 2008 but was subsequently withdrawn.
- What is Dynepo's mechanism of action?
- Not yet disclosed; presumed to stimulate red blood cell production via erythropoietin receptor activation.
- What is Dynepo's route of administration?
- Route of administration not yet disclosed.
- What is Dynepo's modality?
- Small molecule erythropoiesis-stimulating agent.
- What is Dynepo's development status?
- Terminated; program no longer active as of July 2021.
- What is Dynepo's therapeutic class?
- Blood and blood-forming organs (ATC B03); erythropoiesis-stimulating agent.
- Does Dynepo have a partner?
- No partner disclosed; developed by Takeda.
- What trials support Dynepo?
- NCT00514813 is associated with Dynepo; detailed results not yet disclosed.
- Who competes with Dynepo?
- Aranesp (Amgen), Mircera/Neorecormon (Roche), Eporatio (Teva), Retacrit, Evrenzo, Reblozyl.
- Why was Dynepo withdrawn?
- Specific reason not disclosed; likely commercial underperformance in competitive ESA market.
- Is Dynepo a biosimilar?
- No; Dynepo is an original erythropoietin analog, not a biosimilar.
- What is Dynepo's peak sales projection?
- Peak sales projection not yet disclosed.
- When was Dynepo first disclosed?
- First disclosure date not yet disclosed.
- Does Takeda have other ESAs?
- Takeda markets Feraheme and Omontys for anemia; different mechanisms than ESAs.
- What is Dynepo's EU approval number?
- EMEA/H/C/000372.
- Is Dynepo approved in the US?
- US regulatory status not yet disclosed.
- What is Dynepo's internal code?
- SPD490-402.
- Is Dynepo in clinical development?
- No; program terminated, no active development as of July 2021.
- What is the latest Dynepo milestone?
- Program termination and EU authorization withdrawal as of 13 July 2021.
Evidence & sources
- ClinicalTrials.gov NCT00514813 (clinicaltrials)
- epoetin delta EU status (ema)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0002280) (mondo)
- NCT00466297 (clinicaltrials_gov)
- NCT00767702 (clinicaltrials_gov)
- NCT01043133 (clinicaltrials_gov)
- NCT01317979 (clinicaltrials_gov)
- NCT01477281 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- NCT00140517 (clinicaltrials_gov)
- NCT00238043 (clinicaltrials_gov)
- NCT00258024 (clinicaltrials_gov)
- NCT00259142 (clinicaltrials_gov)
- NCT00276224 (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.