Last reviewed 2026-04-22 · How we verify

Dutogliptin + Filgrastim

Recardio, Inc. · Phase 3 active Small molecule

Dutogliptin + Filgrastim is a DPP-4 inhibitor + G-CSF receptor agonist Small molecule drug developed by Recardio, Inc.. It is currently in Phase 3 development for Heart failure with reduced ejection fraction (HFrEF) with glycemic control, Post-myocardial infarction cardiac dysfunction.

Dutogliptin inhibits dipeptidyl peptidase-4 (DPP-4) to enhance incretin signaling and improve glycemic control, while filgrastim stimulates granulocyte colony-stimulating factor (G-CSF) receptors to promote bone marrow recovery and cardiac regeneration. Used for Heart failure with reduced ejection fraction (HFrEF) with glycemic control, Post-myocardial infarction cardiac dysfunction.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Dutogliptin + Filgrastim
Sponsor	Recardio, Inc.
Drug class	DPP-4 inhibitor + G-CSF receptor agonist
Target	DPP-4 enzyme; G-CSF receptor (CD114)
Modality	Small molecule
Therapeutic area	Cardiovascular, Diabetes
Phase	Phase 3

Mechanism of action

Dutogliptin is a DPP-4 inhibitor that increases levels of active GLP-1 and GIP, enhancing insulin secretion and reducing glucagon in a glucose-dependent manner. Filgrastim is a recombinant G-CSF that mobilizes hematopoietic stem cells and promotes their differentiation, potentially supporting cardiac tissue repair and regeneration in the context of heart failure or myocardial injury.

Approved indications

Heart failure with reduced ejection fraction (HFrEF) with glycemic control
Post-myocardial infarction cardiac dysfunction

Common side effects

Bone pain
Injection site reactions
Nasopharyngitis
Headache
Hypoglycemia

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dutogliptin + Filgrastim CI brief — competitive landscape report
Dutogliptin + Filgrastim updates RSS · CI watch RSS
Recardio, Inc. portfolio CI

Frequently asked questions about Dutogliptin + Filgrastim

What is Dutogliptin + Filgrastim?

Dutogliptin + Filgrastim is a DPP-4 inhibitor + G-CSF receptor agonist drug developed by Recardio, Inc., indicated for Heart failure with reduced ejection fraction (HFrEF) with glycemic control, Post-myocardial infarction cardiac dysfunction.

How does Dutogliptin + Filgrastim work?

What is Dutogliptin + Filgrastim used for?

Dutogliptin + Filgrastim is indicated for Heart failure with reduced ejection fraction (HFrEF) with glycemic control, Post-myocardial infarction cardiac dysfunction.

Who makes Dutogliptin + Filgrastim?

Dutogliptin + Filgrastim is developed by Recardio, Inc. (see full Recardio, Inc. pipeline at /company/recardio-inc).

What drug class is Dutogliptin + Filgrastim in?

Dutogliptin + Filgrastim belongs to the DPP-4 inhibitor + G-CSF receptor agonist class. See all DPP-4 inhibitor + G-CSF receptor agonist drugs at /class/dpp-4-inhibitor-g-csf-receptor-agonist.

What development phase is Dutogliptin + Filgrastim in?

Dutogliptin + Filgrastim is in Phase 3.

What are the side effects of Dutogliptin + Filgrastim?

Common side effects of Dutogliptin + Filgrastim include Bone pain, Injection site reactions, Nasopharyngitis, Headache, Hypoglycemia.

What does Dutogliptin + Filgrastim target?

Dutogliptin + Filgrastim targets DPP-4 enzyme; G-CSF receptor (CD114) and is a DPP-4 inhibitor + G-CSF receptor agonist.

Drug class: All DPP-4 inhibitor + G-CSF receptor agonist drugs
Target: All drugs targeting DPP-4 enzyme; G-CSF receptor (CD114)
Manufacturer: Recardio, Inc. — full pipeline
Therapeutic area: All drugs in Cardiovascular, Diabetes
Indication: Drugs for Heart failure with reduced ejection fraction (HFrEF) with glycemic control
Indication: Drugs for Post-myocardial infarction cardiac dysfunction

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing