Tasipimidine: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Tasipimidine, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Tessie® (NADA/ANADA 141-627)
Tessie® NADA 141-627, Original approval, May 06, 2026; sponsor Orion Corp.; species: Dogs; foi_id 18406; FDA PDF
Indication
Treatment of noise aversion and separation anxiety in dogs.
Dose regimen
0.1 mL/kg (30 mcg/kg), Oral, As needed; up to 3 times within 24 hours with at least 3 hours between doses, Reduce future doses to 2/3 of the volume (20 mcg/kg) on veterinary advice if the dog is drowsy or uncoordinated after the test dose. Noise aversion: first dose 1 hour before expected noise or at first signs of anxiety; separation anxiety: 1 hour before leaving the dog alone. Observe the dog for 2 hours after the very first (test) dose. Avoid giving with food; keep at least 1 hour between feeding and dosing.
Tessie® is administered orally at the dose of 0.1 mL/kg (30 mcg/kg). However, it is recommended that a test dose is administered to confirm that this is the correct dose for the dog. Avoid giving the product together with food as absorption may be delayed. Keep at least 1 hour between feeding and dosing.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| cmax | 5.3 ±1.22 ng/mL (mean ± SD) | Day 1 of 28-day study (No. 499681); 30 mcg/kg once daily by oral gavage; Beagle dogs; aqueous tasipimidine sulfate formulation | On the first day of treatment with the proposed label dose of 30 mcg/kg, the mean ± SD maximum tasipimidine plasma concentration (Cmax) was 5.3 ±1.22 ng/mL, the mean ± SD time of maximum plasma concentration (tmax) was 0.7±0.26 hours, and the terminal half-life was 1.6±0.35 hours. |
| tmax | 0.7±0.26 hours (mean ± SD) | Day 1 of 28-day study; 30 mcg/kg oral gavage; Beagle dogs | On the first day of treatment with the proposed label dose of 30 mcg/kg, the mean ± SD maximum tasipimidine plasma concentration (Cmax) was 5.3 ±1.22 ng/mL, the mean ± SD time of maximum plasma concentration (tmax) was 0.7±0.26 hours, and the terminal half-life was 1.6±0.35 hours. |
| half-life | 1.6±0.35 hours (terminal; mean ± SD) | Day 1 of 28-day study; 30 mcg/kg oral gavage; Beagle dogs | On the first day of treatment with the proposed label dose of 30 mcg/kg, the mean ± SD maximum tasipimidine plasma concentration (Cmax) was 5.3 ±1.22 ng/mL, the mean ± SD time of maximum plasma concentration (tmax) was 0.7±0.26 hours, and the terminal half-life was 1.6±0.35 hours. |
| auc | 14.2±2.93 ng*h/mL (AUC0-24h; mean ± SD) | Day 1 of 28-day study; 30 mcg/kg oral gavage; Beagle dogs | The area under plasma concentration-time curve (AUC0-24h) was 14.2±2.93 ng*h/mL. |
| cmax | 4.35±1.36 ng/mL (geometric mean ± SD) after the first dose on Day 182 | 6-month study (No. 20319819); Tessie® 30 mcg/kg twice daily 3 hours apart, oral; Beagle dogs; Day 182 | After 6-month twice daily dosing at 3-hour intervals with the label dose of 30 mcg/kg tasipimidine, the geometric mean ± standard deviation (SD) maximum tasipimidine plasma concentration (Cmax) after the first dose on Day 182 was 4.35±1.36 ng/mL and the median time to maximum concentration (Tmax) was 0.5 hours (range: 0.5-1.5 hours). |
| cmax | 5.39±1.46 ng/mL (geometric mean ± SD) after the second dose on Day 182 | 6-month study; second daily dose of 30 mcg/kg given 3 hours after the first; Beagle dogs | After the second dose on Day 182, the geometric mean ± SD Cmax and half-life were 5.39±1.46 ng/mL and 3.04±1.14 hours, respectively. |
| half-life | 3.04±1.14 hours (geometric mean ± SD) after the second dose on Day 182 | 6-month study; 30 mcg/kg twice daily 3 hours apart; Beagle dogs | After the second dose on Day 182, the geometric mean ± SD Cmax and half-life were 5.39±1.46 ng/mL and 3.04±1.14 hours, respectively. |
| auc | 28.5±1.43 h*ng/mL (AUC0-24hours; geometric mean ± SD) | 6-month study; Day 182; 30 mcg/kg twice daily 3 hours apart; Beagle dogs | The geometric mean ± SD area under the curve from the time of first dosing to the last quantifiable concentration (AUC0-24hours) was 28.5±1.43h*ng/mL. |
Target-animal safety
dose multiples 0X, 1X, 3X, 5X; duration 6 months; twice daily dosing 3 hours apart (final market formulation, oral/oral gavage); animals 8 per group (4 male, 4 female); 4 groups (0X, 1X, 3X, 5X).
Treatment Groups for Study No. 20319819 Treatment Group Dose of Tessie® (mcg/kg)1 Number & Gender of Dogs 1 (0X) 0, vehicle 8 (4 male, 4 female) 2 (1X) 30 8 (4 male, 4 female) 3 (3X) 90 8 (4 male, 4 female) 4 (5X) 150 8 (4 male, 4 female) 1Dogs were dosed twice per day, 3 hours apart.
| Finding | Quote |
|---|---|
| Dose-dependent sedation-related effects in all treated groups (severe ataxia/abnormal gait, lateral recumbency, partly closed eyes, decreased activity, depression); at 1X the signs were of the same type but lower in occurrence and severity | Dogs in all treated groups administered Tessie® showed dose dependent sedation related effects, including severe ataxia/abnormal gait, lateral recumbency, partly closed eyes, decreased activity, and depression. |
| Signs of sedation resolved before the next day's dosing in all dogs | In all dogs, signs of sedation resolved prior to dosing on the next day. |
| Dose-dependent increase in capillary refill time and dry gums; dose-dependent decrease in body temperature, respiratory rate and heart rate with ECG parameter changes but no waveform abnormalities | At all dose levels, sedation was accompanied by a dose-dependent increase in capillary refill time and dry gums, and a dose-dependent decrease in body temperature, respiratory rate, and heart rate with concomitant changes in electrocardiography parameters with no waveform abnormalities. |
| Slight increases in triglycerides, creatine kinase, glutamate dehydrogenase and urea at 3X and 5X; ALP and bile acids also increased at 5X; one 5X dog with irregular heart rate and/or grade II-III murmur from Day 14 | In the 3X and 5X dose groups, slight increases in plasma triglycerides, creatine kinase, glutamate dehydrogenase, and urea were seen. In the 5X group, there were also slight increases in plasma alkaline phosphatase and bile acid concentrations. At 5X, irregular heart rate and/or grade II-III heart murmur were noted in one dog starting at the Day 14 veterinary exam. |
| Study conclusion: supports safety at the maximum label dose of 30 mcg/kg twice daily with 3-hour intervals | Conclusion: This study supports the safety of Tessie® in dogs when administered orally at the maximum label dose of 30 mcg/kg twice daily with 3-hour intervals. |
| 28-day study (No. 499681; 0X/1X/5X/17X once daily oral gavage): at 17X (510 mcg/kg) moderate to severe lethargy, postural/motility changes, uncoordinated movements and/or ptosis on most treatment days | At 510 mcg/kg, dogs showed sedation-related effects: moderate to severe lethargy, with postural/motility changes, mild to moderate uncoordinated movements, and/or ptosis on most days of treatment. |
| 28-day study: dose-dependent decrease in heart rate and blood pressure at all doses | There was a dose-dependent decrease in heart rate and blood pressure at all doses. |
Effectiveness
Pivotal noise-aversion field study (No. V3110005): randomized, double-blind, vehicle-controlled, two parallel groups (1:1), 20 sites in Finland, Germany, Denmark and Portugal; 160 client-owned dogs randomized (80 tasipimidine 30 mcg/kg, 80 vehicle); owner-administered on New Year's Eve fireworks, up to 3 doses with a minimum 3-hour interval; GCP; n = 158 evaluated for effectiveness (79 treated, 79 controls); primary endpoint: Owner global assessment of the effect of treatment on the dog's signs of fear and anxiety on New Year's Eve compared with previous untreated noise events (5-point scale: 1 excellent to 5 worse); result: Good or excellent effect in 43/79 (54%) tasipimidine vs 28/79 (35%) vehicle; OR 2.59 (95% CI 1.27-5.29), p=0.0118. Secondary: sum of the three most severe behaviour scores at 2 h post-dose significantly lower with tasipimidine (estimate -1.20; 95% CI -2.34 to -0.06; p=0.0398).
Primary effectiveness variable: 158 animals (79 treated and 79 controls) were evaluated for effectiveness. For the primary variable, the proportion of dogs with good or excellent treatment effect was higher in dogs administered tasipimidine (43/79, 54%) than in those administered the control (28/79, 35%). See Table II.2 below. The effect of the study treatment on the dogs’ signs of anxiety was significant and in favor of tasipimidine (OR 2.59; 95% Confidence Interval (CI) 1.27-5.29, p=0.0118).
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting (noise-aversion study V3110005) | 5/80 (6%) | 2/80 (3%) | The most common adverse reaction was vomiting, occurring in 6% (5/80) of the dogs administered tasipimidine and in 3% (2/80) of the dogs administered the control. |
| Decreased functional alertness after first dose (unable to walk normally or stand up 2 h post-dose; noise-aversion study, N=80 per group) | 10 (12%) | 4 (5%) | Decreased functional alertness, first dose* 10 (12) 4 (5) |
| Vomiting (separation-anxiety study V3110008) | 29/114 (25%) | 11/109 (10%) | Adverse reaction Tessie® N = 114 Vehicle Control N = 109 Vomiting 29 (25) 11 (10) |
| Lethargy (separation-anxiety study; N=114 Tessie, N=109 vehicle) | 19 (17%) | 4 (4%) | Lethargy 19 (17) 4 (4) |
| Diarrhea (separation-anxiety study; N=114 Tessie, N=109 vehicle) | 14 (12%) | 9 (8%) | Diarrhea 14 (12) 9 (8) |
| Elevated liver enzymes (separation-anxiety study; N=114 Tessie, N=109 vehicle) | 5 (4%) | 3 (2%) | Elevated liver enzymes 5 (4) 3 (2) |
Extraction notes: Original NADA with two pivotal field studies. effectiveness records the noise-aversion study (V3110005). The separation-anxiety pivotal study (V3110008; March 2022-Nov 2024; Finland/Poland/Netherlands/Spain/Portugal/Austria) enrolled 224 client-owned dogs, 199 evaluated for effectiveness (97 Tessie, 102 vehicle); 8-week randomized double-blind vehicle-controlled design, dose 30 mcg/kg 1 h before departure (20 mcg/kg if reduced alertness), up to 2 doses/day; primary endpoint owner assessment at week 8: OR 6.77 (95% CI 3.21-14.3), p<0.0001; rescue criteria met by 60% of controls vs 17% of Tessie dogs. Adverse-reaction table rows are quoted as flattened by PDF extraction: term, then treated n (%), then control n (%). target_animal_safety records the 6-month margin-of-safety study (No. 20319819; 32 Beagles aged 5-6 months, final market formulation); the 28-day study (No. 499681; 24 Beagles aged 7-8 months, 6/group, 0/30/150/510 mcg/kg = 0X/1X/5X/17X once daily oral gavage) supplies PK entries 1-4 and the findings labelled '28-day study'. Dose characterization: 60 mcg/kg was dropped after a handling-anxiety pilot because of more sedation; pilot noise-aversion (43 dogs) and separation-anxiety (12-dog crossover) studies selected 30 mcg/kg.
Reproduce: foi_structured_search(query="Tasipimidine") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).