Last reviewed 2026-05-28 · How we verify

Desidustat Oral Tablet

Zydus Lifesciences Limited · Phase 3 active Small molecule ✓ Verified May 2026

Desidustat Oral Tablet is a PHD inhibitor Small molecule drug developed by Zydus Lifesciences Limited. It is currently in Phase 3 development for Anemia in chronic kidney disease patients not on dialysis, Anemia in dialysis-dependent chronic kidney disease patients.

Desidustat inhibits prolyl hydroxylase domain-containing protein (PHD) enzymes to stabilize hypoxia-inducible factor (HIF) and increase endogenous erythropoietin production.

Desidustat Oral Tablet is a small molecule used to treat anemia in patients with chronic kidney disease, including stages 3 to 5 and those on dialysis. It is being compared to established treatments such as Darbepoetin Alfa and Epoetin Alfa in clinical trials.

Likelihood of approval

58.3% 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).

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	Desidustat Oral Tablet
Sponsor	Zydus Lifesciences Limited
Drug class	PHD inhibitor
Target	Prolyl hydroxylase domain-containing proteins (PHD)
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 3

Mechanism of action

By inhibiting PHD enzymes, desidustat prevents the degradation of HIF-α under normoxic conditions, leading to increased HIF stability and transcriptional activity. This results in upregulation of erythropoietin (EPO) and other HIF-target genes, promoting red blood cell production. This mechanism addresses anemia without requiring exogenous erythropoiesis-stimulating agents.

Approved indications

Anemia in chronic kidney disease patients not on dialysis
Anemia in dialysis-dependent chronic kidney disease patients

Common side effects

Hypertension
Headache
Diarrhea
Nausea
Hyperuricemia

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:

Desidustat Oral Tablet CI brief — competitive landscape report
Desidustat Oral Tablet updates RSS · CI watch RSS
Zydus Lifesciences Limited portfolio CI

Frequently asked questions about Desidustat Oral Tablet

What is Desidustat Oral Tablet?

Desidustat Oral Tablet is a PHD inhibitor drug developed by Zydus Lifesciences Limited, indicated for Anemia in chronic kidney disease patients not on dialysis, Anemia in dialysis-dependent chronic kidney disease patients.

How does Desidustat Oral Tablet work?

Desidustat inhibits prolyl hydroxylase domain-containing protein (PHD) enzymes to stabilize hypoxia-inducible factor (HIF) and increase endogenous erythropoietin production.

What is Desidustat Oral Tablet used for?

Desidustat Oral Tablet is indicated for Anemia in chronic kidney disease patients not on dialysis, Anemia in dialysis-dependent chronic kidney disease patients.

Who makes Desidustat Oral Tablet?

Desidustat Oral Tablet is developed by Zydus Lifesciences Limited (see full Zydus Lifesciences Limited pipeline at /company/zydus-lifesciences-limited).

What drug class is Desidustat Oral Tablet in?

Desidustat Oral Tablet belongs to the PHD inhibitor class. See all PHD inhibitor drugs at /class/phd-inhibitor.

What development phase is Desidustat Oral Tablet in?

Desidustat Oral Tablet is in Phase 3.

What are the side effects of Desidustat Oral Tablet?

Common side effects of Desidustat Oral Tablet include Hypertension, Headache, Diarrhea, Nausea, Hyperuricemia.

What does Desidustat Oral Tablet target?

Desidustat Oral Tablet targets Prolyl hydroxylase domain-containing proteins (PHD) and is a PHD inhibitor.

Drug class: All PHD inhibitor drugs
Target: All drugs targeting Prolyl hydroxylase domain-containing proteins (PHD)
Manufacturer: Zydus Lifesciences Limited — full pipeline
Therapeutic area: All drugs in Hematology
Indication: Drugs for Anemia in chronic kidney disease patients not on dialysis
Indication: Drugs for Anemia in dialysis-dependent chronic kidney disease patients

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