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Carbidopa High-Dose
Carbidopa High-Dose is a Aromatic L-amino acid decarboxylase inhibitor Small molecule drug developed by NYU Langone Health. It is currently in Phase 2 development for Parkinson's disease, Dopa-responsive dystonia. Also known as: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486.
Carbidopa is a decarboxylase inhibitor that prevents the conversion of levodopa to dopamine, thereby increasing the availability of levodopa in the brain.
Carbidopa is a small molecule inhibitor of the enzyme aromatic-L-amino-acid decarboxylase, specifically acting as a DOPA decarboxylase inhibitor. It has been studied in various clinical trials, including those for conditions such as spinal cord injuries, amblyopia, and major depressive disorder.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Carbidopa High-Dose |
|---|---|
| Also known as | Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486 |
| Sponsor | NYU Langone Health |
| Drug class | Aromatic L-amino acid decarboxylase inhibitor |
| Target | Aromatic L-amino acid decarboxylase |
| Modality | Small molecule |
| Therapeutic area | Movement Disorders |
| Phase | Phase 2 |
Mechanism of action
By inhibiting the enzyme aromatic L-amino acid decarboxylase, carbidopa increases the levels of levodopa in the brain, which is then converted to dopamine, a neurotransmitter that helps regulate movement and other functions.
Approved indications
- Parkinson's disease
- Dopa-responsive dystonia
Common side effects
- Nausea
- Vomiting
- Dizziness
- Headache
- Fatigue
Key clinical trials
- Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD) (PHASE2)
- Effects of 5HTP on the Injured Human Spinal Cord (PHASE2, PHASE3)
- Real-Time Levodopa Level Monitoring in Parkinson Disease (NA)
- A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (PHASE1)
- A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD) (PHASE3)
- Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in Healthy Chinese Subjects (PHASE1)
- L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults (PHASE4)
- Carbidopa for the Treatment of Excessive Blood Pressure Variability (PHASE2)
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:
- Carbidopa High-Dose CI brief — competitive landscape report
- Carbidopa High-Dose updates RSS · CI watch RSS
- NYU Langone Health portfolio CI
Frequently asked questions about Carbidopa High-Dose
What is Carbidopa High-Dose?
How does Carbidopa High-Dose work?
What is Carbidopa High-Dose used for?
Who makes Carbidopa High-Dose?
Is Carbidopa High-Dose also known as anything else?
What drug class is Carbidopa High-Dose in?
What development phase is Carbidopa High-Dose in?
What are the side effects of Carbidopa High-Dose?
What does Carbidopa High-Dose target?
Related
- Drug class: All Aromatic L-amino acid decarboxylase inhibitor drugs
- Target: All drugs targeting Aromatic L-amino acid decarboxylase
- Manufacturer: NYU Langone Health — full pipeline
- Therapeutic area: All drugs in Movement Disorders
- Indication: Drugs for Parkinson's disease
- Indication: Drugs for Dopa-responsive dystonia
- Also known as: Lodosyn ®, DL-α-methyl-α-hydrazino-3, 4-dihydroxyphenyl-propionic acid, HMD, MK-486
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing