Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease ( 1 ) FDA label
Also known as rasagiline mesylate, TVP1012, AZILECT®
Rasagiline · 10 trials · 4 indications
The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy.
This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value.
AUC 0-t will be calculated after administration of a single dose of rasagiline.
AUC∞ will be calculated after administration of a single dose of rasagiline.
%AUCext will be calculated after administration of a single dose of rasagiline.
minimum measured plasma concentration at steady state by inspection (Cmin,ss) (multiple dose \[predose concentrations on days 8 and 9\]))
The average plasma concentration at steady state (Cav,ss) is obtained by the calculation: AUCτ/τ, where tau is the dosing interval
Fluctuation at steady state, calculated as (Cmax,ss-Cmin,ss)/Cav,ss
Steady-state accumulation ratio (Rss) calculated as (AUCτ/AUC∞)
| Arm | Type | Description |
|---|---|---|
| 1mg rasagiline | EXPERIMENTAL | 1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) |
| 2mg rasagiline | EXPERIMENTAL | 2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) |
| Placebo | PLACEBO_COMPARATOR | Each arm is followed by 36 weeks of placebo |
| rasagiline mesylate | EXPERIMENTAL | rasagiline mesylate 1 mg oral once daily |
| Experimental 1 | EXPERIMENTAL | 0.5 mg rasagiline mesylate oral once daily |
| Expermental 2 | EXPERIMENTAL | 1.0 mg rasagiline mesylate oral once daily |
| Experimental 2 | EXPERIMENTAL | 1.0 mg rasagiline mesylate oral once daily |
| A | EXPERIMENTAL | Rasagiline treatment |
| B | PLACEBO_COMPARATOR | placebo arm |
| Rasagiline | EXPERIMENTAL | Rasagiline mesylate oral tablets (AZILECT®) are provided at dose strengths of 0.5 and 1 mg (based on rasagiline base). Rasagiline oral tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. |
| Name | Type | Description |
|---|---|---|
| Rasagiline Mesylate | DRUG | tablet, 1mg once daily |
| Placebo | OTHER | Placebo |
| rasagiline mesylate 1.0 mg | DRUG | 1.0 mg rasagiline mesylate |
| tyramine | OTHER | 50 mg once daily |
| 1.0 mg rasagiline mesylate | DRUG | 1.0 mg rasagiline mesylate oral once daily |
| Rasagiline | DRUG | - |
Inclusion Criteria: * Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry. * Subjects with a di...
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Rasagiline is used in Parkinson's disease, including advanced disease with motor fluctuations in patients treated with levodopa/carbidopa. It has also been studied in multiple system atrophy of the parkinsonian subtype and in dementia. It is a small molecule MAOB inhibitor developed by Teva Pharmaceutical Industries Limited.
Rasagiline targets monoamine oxidase B, or MAOB, acting as an inhibitor of that enzyme. This target class is central to its pharmacology as a small molecule agent. Its clinical development spans Parkinson's disease, multiple system atrophy of the parkinsonian subtype, and dementia.
Rasagiline is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva has sponsored clinical studies of the drug across Parkinson's disease, multiple system atrophy of the parkinsonian subtype, and dementia, including both early and later stage trials.
Rasagiline is in Phase 2 development based on its current development stage. It is an investigational small molecule MAOB inhibitor. Completed studies include Phase 1, Phase 2, and Phase 3 trials in Parkinson's disease and multiple system atrophy of the parkinsonian subtype.
Rasagiline has been studied in eight completed trials, including NCT01879748, a Phase 1 pharmacokinetics, safety, and tolerability study; NCT00977665, a Phase 2 trial in multiple system atrophy of the parkinsonian subtype; and NCT00256204 and NCT00203177, Phase 3 trials in Parkinson's disease. Total enrollment across these studies was 2,983 participants.
Yes, rasagiline mesylate is the mesylate salt form of rasagiline, and the two names refer to the same active drug. Rasagiline mesylate is the name used in several clinical trial titles, including the Phase 2 study in multiple system atrophy of the parkinsonian subtype and the Phase 1 pharmacokinetics study.