Levodopa clinical trials
Levodopa is named as an intervention in 2 current clinical trials in our Austria and Israel registers. 1 is recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Merz Therapeutics GmbH (1). The most-studied condition is Parkinson's Disease. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Levodopa is approved
All regulators →Of the three regulators tracked here, the first to approve Levodopa was the US, on 4 Jun 1970. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations (10 May 2001, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Levodopa patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Levodopa, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 21 Oct 2033 (US 12458615).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Levodopa
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Levodopa works
All drug targets →- Dopamine D3 receptor agonist AgonistTarget: DRD3 dopamine receptor D3ChEMBL only
- DyskinesiaPhase 3
- PainPhase 3
- AmblyopiaPhase 3
- Restless legs syndromePhase 3
- Stroke disorderPhase 3
- TimePhase 3
- Angelman syndromePhase 2/3
- AphasiaPhase 2/3
- Cocaine dependencePhase 2/3
- Primary orthostatic hypotensionPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1009, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 3639, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Levodopa
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: InbrijaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Levodopa
- ATC code
- N04BA01
- ChEMBL
- CHEMBL1009
- DrugBank
- DB01235
- PubChem CID
- 6971033
- CAS number
- 59-92-7
- FDA UNII
- 46627O600J
- Wikidata
- Q300989
- Wikipedia
- L-DOPA
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Levodopa
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Real-world Patient Experiences With Inbrija®
NCT07797790 · ClinicalTrials.gov ↗ · Parkinson Disease (PD), Parkinson's Disease, Off Episodes of Parkinson Disease
|
Observational | Recruiting | Merz Therapeutics GmbH | Austria |
|
Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics
NCT07793461 · ClinicalTrials.gov ↗ · Parkinson's Disease
|
Phase 4 | Not yet open | Beth Israel Deaconess Medical Center | Israel |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Levodopa in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Levodopa. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Evaluating the effect of inhaled levodopa (Inbrija®) for early morning off in Parkinson’s disease
2026-526465-18-00 · Nervous System Diseases
|
Phase 3 | Authorised | Region Hovedstaden | Denmark |
Levodopa across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
5 single-substance products containing Levodopa on the HPRA medicines list.
- Hopledo 140 mg/35 mg modified-release hard capsulesZambon S.p.A. · EU/1/26/2054/001
- Hopledo 210 mg/52.5 mg modified-release hard capsulesZambon S.p.A. · EU/1/26/2054/002
- Hopledo 280 mg/70 mg modified-release hard capsulesZambon S.p.A. · EU/1/26/2054/003
- Hopledo 350 mg/87.5 mg modified-release hard capsulesZambon S.p.A. · EU/1/26/2054/004
- Inbrija 33 mg inhalation powder, hard capsulesMerz Pharmaceuticals GmbH · EU/1/19/1390/001-002
Supply shortages
No entry for Levodopa in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
Conditions studied with Levodopa
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Merz Therapeutics GmbH | 1 |
| Beth Israel Deaconess Medical Center | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Austria | 1 | 1 |
| Clinical trials in Israel | 1 | 0 |
| EU register (CTIS) | 1 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Levodopa trials
How many clinical trials are testing Levodopa?
2 current trials in our Austria and Israel registers name Levodopa as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Levodopa trials recruiting patients?
Yes. 1 of the 2 trials is recruiting: 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Levodopa clinical trials?
Merz Therapeutics GmbH (1) and Beth Israel Deaconess Medical Center (1). The number in brackets is how many trials each organisation leads.
Is Levodopa licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Levodopa, for example Hopledo 140 mg/35 mg modified-release hard capsules (Zambon S.p.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Levodopa shortage?
Not in the lists we track: Levodopa has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Levodopa works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Levodopa works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Levodopa (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.