Hopledo
Authorised
This medicine is authorised for use in the European Union
levodopa / carbidopa
MedicineHumanAuthorised
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Overview
Hopledo is a medicine used to treat patients with Parkinson’s disease and moderate to severe motor fluctuations (changes in the ability to move) when these cannot be adequately controlled with a standard treatment including levodopa and an inhibitor of dopa decarboxylase taken by mouth.
Parkinson’s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Motor fluctuations happen when the effects of the medication taken by mouth wear off and symptoms return. Patients experience sudden switches between being ‘on’ and able to move and being ‘off’ and having difficulty moving about.
Hopledo contains the active substances levodopa and carbidopa.
Hopledo is available as capsules in four different strengths. The starting dose depends on the dose of levodopa and dopa decarboxylase inhibitor patients have previously taken. The doctor may then adjust the dose depending on how the condition responds to treatment to Hopledo.
The medicine can only be obtained with a prescription. For more information about using Hopledo, see the package leaflet or contact your doctor or pharmacist.
In patients with Parkinson’s disease, the cells in the brain produce less dopamine, a neurotransmitter important for controlling movement. Hopledo contains levodopa, which is turned into dopamine in the brain; this helps to restore dopamine levels. The carbidopa in Hopledo stops levodopa from being turned into dopamine before it reaches the brain.
The combination of levodopa and carbidopa is used in other medicines for Parkinson’s disease. In Hopledo capsules, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels. These types of capsules are known as modified-release capsules.
In a main study involving 506 patients with Parkinson’s disease who experienced motor fluctuations which were not controlled by their current medication, Hopledo was compared with another treatment containing levodopa and carbidopa given as immediate-release capsules (which allow both active substances to be released immediately). The study looked at the changes in the time patients’ Parkinson’s symptoms were well controlled without involuntary movements (‘on time’), as assessed by patients using a Parkinson’s disease diary.
After 13 weeks of treatment, patients taking Hopledo had an increase in their daily ‘on’ time of 0.53 hours, compared with those taking immediate-release carbidopa / levodopa. They also had a reduction of about 0.48 hours per day in ‘off time’, the periods when a person’s medication wears off and their motor symptoms return or worsen, compared with patients taking the immediate-release capsules.
In addition, more patients on Hopledo (around 30%) reported that their condition was ‘much improved’ or ‘very much improved’ on the Patient Global Impression of Change (PGIC) scale, compared with those taking the comparator treatment (around 19%).
Studies carried out with Hopledo are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Hopledo, see the package leaflet.
The most common side effects with Hopledo (which may affect up to 1 in 10 people) include dyskinesia (difficulty controlling movements), nausea (feeling sick), dry mouth and dizziness.
Some side effects can be serious. Events including hallucination (seeing, hearing or feeling things that are not there), delirium (confusion) and psychotic disorders (severe mental disorders that cause abnormal thinking and perceptions) were reported in clinical studies with Hopledo (in up to 1 in 100 people).
Hopledo must not be used in patients with narrow angle glaucoma (damage to the nerve in the eye caused by pressure inside the eye rising rapidly because fluid cannot drain out) or pheochromocytoma (a tumour of the adrenal glands). It must also not be used in patients taking certain medicines used to treat Parkinson’s disease or depression known as non-selective monoamine oxidase inhibitors (MAOI) such as phenelzine and tranylcypromine, or in patients with a history of certain medical conditions.
Levodopa used in combination with carbidopa is the gold standard treatment for Parkinson’s disease. However, standard (immediate release) levodopa treatment, along with the natural progression of the disease, commonly leads to difficulty controlling movements. These complications occur because taking immediate-release levodopa and carbidopa causes varying levels of levodopa in the blood throughout the day, leading to fluctuations in symptom control. Hopledo provides a more stable levodopa delivery and has been shown to be more effective than immediate release levodopa and carbidopa in controlling symptoms without motor complications. Although the improvement in symptom control was modest, Hopledo requires fewer doses during the day, and this could be of benefit especially for older patients.
Regarding safety, the side effects of Hopledo are similar to those already known for levodopa / carbidopa treatments. However, older patients (especially those aged 75 years or older) and patients with kidney impairment experienced more side effects in the studies, and this is highlighted in the product information.
The European Medicines Agency decided that Hopledo’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hopledo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Hopledo are continuously monitored. Suspected side effects reported with Hopledo are carefully evaluated and any necessary action is taken to protect patients.
Hopledo received a marketing authorisation valid throughout the EU on 20 August 2026.
For information about the availability of this medicine in your country, contact your national competent authority.
Product information
20/08/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Pharmacotherapeutic group
Anti-Parkinson drugsTherapeutic indication
Hopledo is indicated for the 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.
News on Hopledo
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