Review section

Field	Value
Drug	Juvmo (tavapadon)
Indication reviewed	Parkinson's disease
Therapeutic category	Non-ergot dopamine agonists (selective dopamine D1/D5 receptor partial agonist)
Manufacturer	AbbVie
Regulatory status	Approved September 25, 2026
Data as of	September 27, 2026
Prepared by	To be completed by the reviewing plan
Review status	Draft for pharmacy and therapeutics committee review

Indications

Table 1. FDA-approved indications

Indications	Juvmo (tavapadon)
“treatment of Parkinson’s disease (PD) in adults”	✓

Populations in which efficacy was established

“The efficacy of JUVMO for the treatment of PD in adults not on concomitant levodopa was established in two 27-week randomized, multicenter, double-blind, placebo-controlled studies, Study 1 (NCT04201093) and Study 2 (NCT04223193).” (opens the prescribing information at this quote)
“The efficacy of JUVMO for the treatment of PD as adjunctive therapy to levodopa was established in a 27-week, double-blind, randomized, placebo-controlled, parallel-group, flexible-dose trial, Study 3 (NCT04542499).” (opens the prescribing information at this quote)

Age limit of the indication

“Safety and effectiveness in pediatric patients have not been established.” (opens the prescribing information at this quote)

Pharmacokinetics

Table 2. Pharmacokinetic parameters

Generic Name(s)	Bioavailability	Protein Binding	Metabolism	Excretion	Half-Life
Tavapadon	Not reported	“93% (primarily albumin)”	“Tavapadon and its major inactive metabolite M4 are primarily metabolized by CYP3A.”	“Unchanged tavapadon was a minor component in both urine and feces (less than 1%).”“Metabolite M4 accounted for less than 5% of the administered dose in both urine and feces.”	“The mean elimination half-life of tavapadon is approximately 25.5 hours.”

Absorption, food effect, and distribution

“Following oral administration of JUVMO, tavapadon is absorbed with peak plasma concentrations (Cmax) at approximately 2 to 4 hours. Tavapadon displays dose-proportional pharmacokinetics within the maintenance dose range of 5 mg to 15 mg.” (opens the prescribing information at this quote)
“When JUVMO was administered with a high-fat/high-calorie meal, the food effect was not significant (AUCτ and Cmax were increased by approximately 10% and 12%, respectively, with no effect on median time to Cmax).” (opens the prescribing information at this quote)
“The apparent volume of distribution of tavapadon is 63.5 L.” (opens the prescribing information at this quote)

Renal and hepatic impairment

“No clinically significant differences in pharmacokinetics of tavapadon were observed based on age (21 years to 79 years), sex, body weight (56 kg to 119 kg), race, severe renal impairment not requiring dialysis (eGFR < 30 mL/min estimated by CKD-EPI equation), mild hepatic impairment (Child-Pugh Class A), or moderate hepatic impairment (Child-Pugh Class B).” (opens the prescribing information at this quote)
“The effects of renal impairment in patients with eGFR < 15 mL/min or on dialysis and severe hepatic impairment (Child-Pugh Class C) on tavapadon pharmacokinetics have not been studied.” (opens the prescribing information at this quote)

Drug interactions

Table 3. Major drug interactions

Generic Name(s)	Interaction	Mechanism
Tavapadon	Strong CYP3A inhibitors	“Tavapadon is CYP3A substrate. Concomitant use of strong and moderate CYP3A inhibitors increase the exposure of tavapadon, which may increase the risk of adverse reactions”“Concomitant use of strong CYP3A inhibitors may increase the risk of hallucinations”“Concomitant administration of itraconazole (200 mg daily for 14 days), a strong CYP3A inhibitor, with JUVMO increased tavapadon AUCτ and Cmax by 5-fold and 4-fold, respectively.”“Avoid concomitant use of strong or moderate CYP3A inhibitors during titration of JUVMO.”“If JUVMO is used with a strong or moderate CYP3A inhibitor during JUVMO maintenance, reduce JUVMO dosage frequency”Maintenance: “5 mg every 7 days”“10 mg every 7 days”“15 mg every 7 days”“steady-state AUC₀₋₂₄ and Cmax, daily are predicted to fluctuate between +84% to -23% and +50% to -41%, respectively, across the 7-day dosing interval relative to once daily dosing of JUVMO without an inhibitor, with values highest on Day 1 of the dosing week”
Tavapadon	Moderate CYP3A inhibitors	“Tavapadon is CYP3A substrate. Concomitant use of strong and moderate CYP3A inhibitors increase the exposure of tavapadon, which may increase the risk of adverse reactions”“Concomitant administration of fluconazole (200 mg daily), a moderate CYP3A inhibitor, with 15 mg JUVMO at steady-state is predicted to increase the AUCτ and Cmax of tavapadon by approximately 2.6-fold and 2.3-fold, respectively.”“Avoid concomitant use of strong or moderate CYP3A inhibitors during titration of JUVMO.”“If JUVMO is used with a strong or moderate CYP3A inhibitor during JUVMO maintenance, reduce JUVMO dosage frequency”Maintenance: “5 mg every 3 days”“10 mg every 3 days”“15 mg every 3 days”“steady-state AUC₀₋₂₄ and Cmax, daily fluctuate between +14% to -40% and +1 to -43%, respectively from Day 1 to Day 3 of the dosing interval, relative to once daily dosing without an inhibitor.”
Tavapadon	Strong CYP3A inducers	“Tavapadon is CYP3A substrate. Concomitant use of strong or moderate CYP3A inducer decreases the exposure of tavapadon which may result in reduced JUVMO efficacy”“Concomitant administration of carbamazepine (300 mg twice daily), a strong CYP3A inducer, with JUVMO decreased tavapadon AUCτ and Cmax by 63% and 49%, respectively”“Avoid concomitant use of strong CYP3A inducers during titration and maintenance of JUVMO.”
Tavapadon	Moderate CYP3A inducers	“Tavapadon is CYP3A substrate. Concomitant use of strong or moderate CYP3A inducer decreases the exposure of tavapadon which may result in reduced JUVMO efficacy”“Concomitant administration of efavirenz (600 mg), a moderate CYP3A inducer, with 15 mg JUVMO is predicted to decrease the AUCτ and Cmax of tavapadon by 70% and 58%, respectively.”“If JUVMO is used in a patient already on a long-term moderate CYP3A inducer, increase JUVMO dosage frequency”“Day 8 and thereafter during concomitant use: increase the frequency of the maintenance dosage of JUVMO to twice daily. If needed, based on clinical response and tolerability, the maintenance dosage can be increased to three times daily.”“Upon discontinuation of moderate CYP3A inducers, gradually reduce the JUVMO dosage to once daily.”
Tavapadon	CYP3A substrates	“JUVMO is an inducer of CYP3A”“Concomitant use of JUVMO may decrease the concentrations of CYP3A substrates.”“Consider a dose modification of sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, as clinically appropriate, when initiating or discontinuing JUVMO.”
Tavapadon	CYP2C8 substrates	“JUVMO is an inhibitor of CYP2C8”“Concomitant use of JUVMO may increase the plasma concentrations of CYP2C8 substrates.”“Consider a dosage reduction of sensitive CYP2C8 substrates or CYP2C8 substrates where minimal concentration changes may increase the risk of severe adverse reactions, as clinically appropriate, when concomitantly used with JUVMO.”
Tavapadon	BCRP substrates	“JUVMO is an inhibitor of efflux transporter BCRP”“Concomitant use of JUVMO may increase the exposure of BCRP substrates.”“Consider a dosage reduction of BCRP substrates, as clinically appropriate, when concomitantly used with JUVMO.”

Abbreviations: AUCτ=area under the plasma concentration-time curve over the dosing interval; AUC₀₋₂₄=area under the plasma concentration-time curve from 0 to 24 hours; BCRP=breast cancer resistance protein; Cmax=maximum plasma concentration; Cmax, daily=maximum plasma concentration on each day of the dosing interval; CYP=cytochrome P450

Adverse drug events

Table 4a. Adverse drug events reported in 3% or more of patients and at least 2% more often than with placebo in the 27-week Study 1 and Study 2 (without concomitant levodopa)

Adverse Event	Juvmo (N = 505), %	Placebo (N = 328), %
Nausea	“27”	“2”
Headache	“17”	“5”
Dizziness	“14”	“4”
Fatigue	“10”	“3”
Dysgeusia	“8”	“0”
Vomiting	“7”	“<1”
Dry mouth	“5”	“<1”
Anxiety	“5”	“2”
Hypotension	“4”	“1”
Dyspepsia	“4”	“1”
Abnormal dreams	“4”	“<1”
Orthostatic hypotension	“4”	“<1”
Hallucination	“3”	“0”
Gastroesophageal reflux disease	“3”	“<1”
Constipation	“3”	“1”

Table 4b. Adverse drug events reported in 3% or more of patients and at least 2% more often than with placebo in the 27-week Study 3 (with concomitant levodopa)

Adverse Event	Juvmo (N = 251), %	Placebo (N = 254), %
Nausea	“14”	“4”
Dyskinesia	“10”	“2”
Dizziness	“8”	“3”
Headache	“7”	“3”
Hallucination	“7”	“1”
Orthostatic hypotension	“6”	“1”
Hypotension	“4”	“<1”
Abdominal pain	“3”	“<1”
Asthenia	“3”	“0”

Grouped terms in Tables 4a and 4b

“Headache includes multiple related terms” (opens the prescribing information at this quote)
“Fatigue includes asthenia” (opens the prescribing information at this quote)
“Hallucination includes multiple related terms” (opens the prescribing information at this quote)

Discontinuation due to adverse reactions

“Adverse reactions led to discontinuation of JUVMO in 100 of 505 patients (20%). Of the 100 patients receiving JUVMO who discontinued because of an adverse reaction, 85 (85%) did so during the titration and/or adjustment phases. The most common adverse reactions leading to discontinuation in patients taking JUVMO were nausea, dizziness, headache, and vomiting.” (opens the prescribing information at this quote)

“Adverse reactions led to discontinuation of JUVMO in 43 of 251 patients (17%). Of the 43 patients receiving JUVMO who discontinued because of an adverse reaction, 38 (88%) did so during the titration and adjustment phases. The most common adverse reactions leading to discontinuation included nausea, dyskinesia, visual hallucination, and dizziness.” (opens the prescribing information at this quote)

Incidences reported under warnings and precautions that the tables do not carry

“In Study 1 and Study 2, impulse control disorders were reported in 1% of patients treated with JUVMO compared to no patients on placebo. In Study 3, impulse control disorders were reported in 2% of patients treated with JUVMO compared to 1% of patients on placebo.” (opens the prescribing information at this quote)
“In Study 1 and Study 2, 0.6% of patients with PD treated with JUVMO reported dyskinesia compared with no patients on placebo.” (opens the prescribing information at this quote)
“In Study 1 and Study 2, among patients 65 years of age and older, hallucination was reported in 4% of patients treated with JUVMO compared to no patients on placebo. In Study 3, among patients 65 years of age and older, hallucination was reported in 9% of patients treated with JUVMO compared to 1% of patients on placebo.” (opens the prescribing information at this quote)

Dosing and administration

Table 5. Usual dosing regimens

Generic Name	Usual Adult Dose	Usual Pediatric Dose	Availability
Tavapadon	“Administer JUVMO orally once daily with or without food.”“Recommended maintenance dosage is 5 mg orally once daily. The dosage may be increased to a maximum of 15 mg once daily based on tolerability and clinical response.”	“Safety and effectiveness in pediatric patients have not been established.”	“Tablets: 0.25 mg, 1 mg, 5 mg, 10 mg, and 15 mg”

See the current prescribing information for full details.

Titration schedule

Treatment Days	Juvmo Dosage
“Days 1 to 4”	“0.25 mg once daily”
“Days 5 to 8”	“0.5 mg once daily”
“Days 9 to 12”	“0.75 mg once daily”
“Days 13 to 16”	“1 mg once daily”
“Days 17 to 20”	“1.5 mg once daily”
“Days 21 to 24”	“2.25 mg once daily”
“Days 25 to 40”	“3 mg once daily”
“Day 41 and thereafter”	“5 mg once daily”

“The JUVMO titration pack is recommended for patients initiating therapy with JUVMO to provide doses consistent with the recommended titration schedule to reach the 5 mg maintenance dosage” (opens the prescribing information at this quote)
“If needed, based on tolerability and clinical response, the maintenance dose may be increased in increments of 5 mg approximately every 15 days to the maximum recommended daily dosage.” (opens the prescribing information at this quote)
“Dose and titration should be guided by tolerability and clinical response. If required, longer intervals between dose adjustment can be used.” (opens the prescribing information at this quote)

Missed dose

“If a dose of JUVMO is missed, take it as soon as remembered on the same day, but do not double the dose. Do not take a missed dose on the following day. Skip the missed dose and resume the regular dosing schedule.” (opens the prescribing information at this quote)

Effectiveness

Table 6. Comparative clinical trials

Study and Drug Regimen	Study Design and Demographics	Study Size and Duration	End Points	Results
Study 1 (TEMPO-1, NCT04201093): “randomized 1:1:1 to receive JUVMO 5 mg (N = 177), JUVMO 15 mg (N = 177), or placebo (N = 175) once daily”	“27-week randomized, multicenter, double-blind, placebo-controlled studies”“modified Hoehn and Yahr stage of 1, 1.5, or 2”“Part II score ≥2 and an MDS-UPDRS Part III score ≥10”“not receiving medications to treat Parkinson’s disease (e.g., levodopa) other than concomitant stable dose of an MAO-B inhibitor”“Patients had a mean age of 63.7 years (range: 40 to 80 years), 65% were male, 97% were White, and 6% were Hispanic. The mean duration of PD at baseline was 0.8 years (range: 0 to 3 years).”	“529 patients”“27-week treatment period”“58-week open-label treatment period”	“Efficacy was determined based on the change from baseline in the MDS-UPDRS Part II score at Week 26.”	LS mean change (SE) from baseline to Week 26: Juvmo 5 mg “-1.6 (0.31)”Juvmo 15 mg “-1.7 (0.32)”Placebo “0.9 (0.30)”LSMD vs placebo (95% CI): Juvmo 5 mg “-2.5 (-3.3, -1.7)”Juvmo 15 mg “-2.6 (-3.4, -1.7)”“p-value <0.0001 <0.0001”
Study 2 (TEMPO-2, NCT04223193): “randomized 1:1 to receive JUVMO 5 mg to 15 mg (N = 151) or placebo (N = 153) once daily”	“27-week randomized, multicenter, double-blind, placebo-controlled studies”“modified Hoehn and Yahr stage of 1, 1.5, or 2”“Part II score ≥2 and an MDS-UPDRS Part III score ≥10”“not receiving medications to treat Parkinson’s disease (e.g., levodopa) other than concomitant stable dose of an MAO-B inhibitor”“Patients had a mean age of 62.9 years (range: 40 to 80 years), 56% were male, 88% were White, 11% were Asian, and 5% were Hispanic. The mean duration of PD at baseline was 0.9 years (range: 0 to 3 years).”	“304 patients”“27-week treatment period”“58-week open-label treatment period”	“Efficacy was determined based on the change from baseline in the MDS-UPDRS Part II score at Week 26.”	LS mean change (SE) from baseline to Week 26: Juvmo “-1.5 (0.33)”Placebo “0.0 (0.30)”LSMD vs placebo (95% CI): “-1.5 (-2.4, -0.6)”“p-value 0.0007”
Study 3 (TEMPO-3, NCT04542499): “randomized 1:1 to receive JUVMO 5 mg to 15 mg (N = 252) or placebo (N = 255) once daily as adjunctive therapy to the pre-study levodopa dose”	“27-week, double-blind, randomized, placebo-controlled, parallel-group, flexible-dose trial”“minimum stable dose of levodopa of 400 mg per day divided at least 3 or 4 times daily depending on dose formulation”“No changes in levodopa were allowed during study participation.”“Patients had a mean age of 64.9 years (range: 43 to 80 years), 63% were male, 97% were White, and 5% were Hispanic. The mean duration of PD at baseline was 6.7 years (range: 0.1 to 30.9 years).”	“507 patients”“27-week”	Primary: “change from baseline in the total daily ON time without troublesome dyskinesia at Week 26 based on the self-completed home diary for motor function status (Hauser diary)”Key secondary: “change from baseline in total daily OFF time to Week 26”	ON time without troublesome dyskinesia (hours), change from baseline to Week 26: Juvmo “1.7 (0.21)”Placebo “0.6 (0.19)”Difference: “1.1 (0.6, 1.7)”“p-value <0.0001”OFF time (hours), change from baseline to Week 26: Juvmo “-1.9 (0.20)”Placebo “-0.9 (0.18)”Difference: “-0.9 (-1.5, -0.4)”“p-value 0.0006”

Abbreviations: CI=confidence interval; LS=least squares; LSMD=least squares mean difference; MAO-B=monoamine oxidase type B; MDS-UPDRS=Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale; PD=Parkinson's disease; SE=standard error

Study 3 motor-state eligibility criteria

“modified Hoehn and Yahr score of 2, 2.5, or 3 in the “ON” state;” (opens the prescribing information at this quote)
“minimum of 2.5 hours of “OFF” time on 2 consecutive days;” (opens the prescribing information at this quote)

Protocol primary endpoint of Study 1 and Study 2, which the prescribing information does not report

“The primary end point was the change from baseline to week 26 (primary efficacy time point) in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part II (motor aspects of experiences of daily living) and part III (motor evaluation) combined score. Key secondary end points were the change from baseline to week 26 in the MDS-UPDRS part II score and the percentage of participants who had a Patient Global Impression of Change (PGIC) score of “much improved” or “very much improved” at week 26 (PGIC responders).” (opens the source at this quote in a new tab)
“The change from baseline to week 26 in the MDS-UPDRS parts II and III combined score was significantly improved in both the 5-mg tavapadon group (least-squares mean [LSM] decrease of 9.7 points vs increase of 1.8 points with placebo; LSM treatment difference, −11.5; 95% CI, −13.8 to −9.2; P < .001; d = 1.14) and 15-mg tavapadon group (LSM decrease of 10.2 points vs increase of 1.8 points with placebo; LSM treatment difference, −12.1; 95% CI, −14.4 to −9.8; P < .001; d = 1.20). Improvements in MDS-UPDRS parts II and III combined scores in tavapadon-treated vs placebo-treated participants were observed as early as week 5 and continued through the end of treatment (Figure 2A).” (opens the source at this quote in a new tab)

“The primary endpoint of change from baseline to week 26 in the MDS-UPDRS Parts II and III combined score was significantly improved with tavapadon versus placebo (least squares mean [LSM] decrease of 10·3 [95% CI −12·2 to −8·3] points vs 1·2 [−2·9 to 0·6] points; LSM treatment difference −9·1 [95% CI −11·7 to −6·5]; p<0·0001).” (opens the source at this quote in a new tab)