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/Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion
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Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion

EMA
2026/06/26

Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion

  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hopledo, intended for the treatment of adults with Parkinson's disease and moderate to severe motor fluctuations.

The applicant for this medicinal product is Zambon S.p.A.

Hopledo will be available as 140 mg / 35 mg, 210 mg / 52.5 mg, 280 mg / 70 mg and 350 mg / 87.5 mg modified-release hard capsules. The active substances of Hopledo are levodopa and carbidopa, dopaminergic agents (ATC code: N04BA02). Hopledo modified-release hard capsules contain immediate-release granules and extended-release beads. The immediate-release granules consist of levodopa and carbidopa with a disintegrant polymer to allow for rapid dissolution. The extended-release beads consist of levodopa, coated with a sustained-release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the beads adhered to the area of absorprion longer and an enteric coating to prevent the beads from disintegrating too early in the stomach.

The benefits of Hopledo are its ability to increase levodopa plasma concentrations and provide relief from motor fluctuations (alternating changes in the ability to move) in adults with Parkinson's disease when these fluctuations are not sufficiently controlled with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens.

The most common side effects with Hopledo include dyskinesia, nausea, dry mouth and dizziness.

The full indication is:

Treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor based treatment regimens.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Hopledo

Adopted

Reference Number:

EMADOC-1829012207-54127

English (EN) (153.53 KB - PDF)

First published:

26/06/2026

View

Product details

Name of medicine

Hopledo

Active substance

  • carbidopa monohydrate
  • levodopa

International non-proprietary name (INN) or common name

  • levodopa
  • carbidopa

Therapeutic area (MeSH)

Parkinson Disease

Anatomical therapeutic chemical (ATC) code

N04BA02

EMA product number

EMEA/H/C/006629

Marketing authorisation applicant

Zambon SpA

Opinion adopted

25/06/2026

Opinion status

Positive

News on Hopledo

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026

26/06/2026

This page was last updated on

26/06/2026

Summary

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hopledo, intended for the treatment of adults with Parkinson's disease and moderate to severe motor fluctuations. The applicant for this medicinal product is Zambon S.p.A. Hopledo will be available as 140 mg / 35 mg, 210 mg / 52.5 mg, 280 mg / 70 mg and 350 mg / 87.5 mg modified-release hard capsules. The active substances of Hopledo are levodopa and carbidopa, dopaminergic agents (ATC code: N04BA02). Hopledo modified-release hard capsules contain immediate-release granules and extended-release beads. The immediate-release granules consist of levodopa and carbidopa with a disintegrant polymer to allow for rapid dissolution. The extended-release beads consist of levodopa, coated with a sustained-release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the beads adhered to the area of absorprion longer and an enteric coating to prevent the beads from disintegrating too early in the stomach. The benefits of Hopledo are its ability to increase levodopa plasma concentrations and provide relief from motor fluctuations (alternating changes in the ability to move) in adults with Parkinson's disease when these fluctuations are not sufficiently controlled with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. The most common side effects with Hopledo include dyskinesia, nausea, dry mouth and dizziness. The full indication is: Treatment of adult patients with Parkinson's disease and moderate to severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor based treatment regimens. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.