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Levodopa Carbidopa immediate release tablets
Levodopa Carbidopa immediate release tablets is a Small molecule drug developed by Desitin Arzneimittel GmbH. It is currently in Phase 1 development. Also known as: isicom 100/25 mg, Nacom 100/25 mg.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Levodopa Carbidopa immediate release tablets |
|---|---|
| Also known as | isicom 100/25 mg, Nacom 100/25 mg |
| Sponsor | Desitin Arzneimittel GmbH |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Research on Translational Outcomes of Alcohol (Project RETRO) (PHASE4)
- A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations (PHASE3)
- A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease (PHASE2)
- A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease (PHASE3)
- A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). (PHASE3)
- Bioequivalence Bewteen DopaSnap® (Cabidopa/Levopdoap 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet (Actavis) (PHASE1)
- Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease (PHASE2)
- Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease (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:
- Levodopa Carbidopa immediate release tablets CI brief — competitive landscape report
- Levodopa Carbidopa immediate release tablets updates RSS · CI watch RSS
- Desitin Arzneimittel GmbH portfolio CI
Frequently asked questions about Levodopa Carbidopa immediate release tablets
What is Levodopa Carbidopa immediate release tablets?
Who makes Levodopa Carbidopa immediate release tablets?
Is Levodopa Carbidopa immediate release tablets also known as anything else?
What development phase is Levodopa Carbidopa immediate release tablets in?
Related
- Manufacturer: Desitin Arzneimittel GmbH — full pipeline
- Also known as: isicom 100/25 mg, Nacom 100/25 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing