Last reviewed 2026-06-01 · How we verify

Anagrelide retard

AOP Orphan Pharmaceuticals AG · Phase 3 active Small molecule ✓ Verified Jun 2026

Anagrelide retard is a Phosphodiesterase 3 inhibitor Small molecule drug developed by AOP Orphan Pharmaceuticals AG. It is currently in Phase 3 development for Essential thrombocythemia (ET) — reduction of elevated platelet counts, Polycythemia vera with thrombocytosis. Also known as: Anagrelide retard 2 mg film coated tablet, ANAT2.

Anagrelide is a phosphodiesterase 3 inhibitor that reduces platelet production by inhibiting megakaryocyte maturation and proliferation.

Anagrelide retard is a small molecule inhibitor of the phosphodiesterase 3 enzyme, used to treat Essential Thrombocythemia. It is a Phase III medication that has been studied in clinical trials, including a randomized, multicenter, double-blind, active controlled study to compare its efficacy to Thromboreductin.

Likelihood of approval

61.3% 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).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

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	Anagrelide retard
Also known as	Anagrelide retard 2 mg film coated tablet, ANAT2
Sponsor	AOP Orphan Pharmaceuticals AG
Drug class	Phosphodiesterase 3 inhibitor
Target	Phosphodiesterase 3 (PDE3)
Modality	Small molecule
Therapeutic area	Hematology/Oncology
Phase	Phase 3

Mechanism of action

Anagrelide works primarily through inhibition of phosphodiesterase 3 (PDE3), which leads to decreased platelet aggregation and reduced megakaryocyte proliferation. The retard formulation provides extended-release delivery to maintain therapeutic levels while potentially improving tolerability. It is used to reduce elevated platelet counts in patients with thrombocythemia.

Approved indications

Essential thrombocythemia (ET) — reduction of elevated platelet counts
Polycythemia vera with thrombocytosis

Common side effects

Headache
Palpitations
Diarrhea
Dizziness
Tachycardia

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:

Anagrelide retard CI brief — competitive landscape report
Anagrelide retard updates RSS · CI watch RSS
AOP Orphan Pharmaceuticals AG portfolio CI

Frequently asked questions about Anagrelide retard

What is Anagrelide retard?

Anagrelide retard is a Phosphodiesterase 3 inhibitor drug developed by AOP Orphan Pharmaceuticals AG, indicated for Essential thrombocythemia (ET) — reduction of elevated platelet counts, Polycythemia vera with thrombocytosis.

How does Anagrelide retard work?

Anagrelide is a phosphodiesterase 3 inhibitor that reduces platelet production by inhibiting megakaryocyte maturation and proliferation.

What is Anagrelide retard used for?

Anagrelide retard is indicated for Essential thrombocythemia (ET) — reduction of elevated platelet counts, Polycythemia vera with thrombocytosis.

Who makes Anagrelide retard?

Anagrelide retard is developed by AOP Orphan Pharmaceuticals AG (see full AOP Orphan Pharmaceuticals AG pipeline at /company/aop-orphan-pharmaceuticals-ag).

Is Anagrelide retard also known as anything else?

Anagrelide retard is also known as Anagrelide retard 2 mg film coated tablet, ANAT2.

What drug class is Anagrelide retard in?

Anagrelide retard belongs to the Phosphodiesterase 3 inhibitor class. See all Phosphodiesterase 3 inhibitor drugs at /class/phosphodiesterase-3-inhibitor.

What development phase is Anagrelide retard in?

Anagrelide retard is in Phase 3.

What are the side effects of Anagrelide retard?

Common side effects of Anagrelide retard include Headache, Palpitations, Diarrhea, Dizziness, Tachycardia.

What does Anagrelide retard target?

Anagrelide retard targets Phosphodiesterase 3 (PDE3) and is a Phosphodiesterase 3 inhibitor.

Drug class: All Phosphodiesterase 3 inhibitor drugs
Target: All drugs targeting Phosphodiesterase 3 (PDE3)
Manufacturer: AOP Orphan Pharmaceuticals AG — full pipeline
Therapeutic area: All drugs in Hematology/Oncology
Indication: Drugs for Essential thrombocythemia (ET) — reduction of elevated platelet counts
Indication: Drugs for Polycythemia vera with thrombocytosis
Also known as: Anagrelide retard 2 mg film coated tablet, ANAT2

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