Bioequivalence
Under the FDA’s 505(b)(2) pathway, TASCENSO ODT was shown to have the same pharmacokinetics (PK) profile as Gilenya® (fingolimod) capsules, meaning the rate and extent of exposure of the drug is the same for both formulations. Therefore, the two products are considered bioequivalent.1
- Same proven fingolimod
- Same safety, same efficacy and the same side effects
- Not a generic2
Not only could the unique formulation of TASCENSO ODT be well suited to your patients, it also means TASCENSO ODT cannot be substituted by Gilenya® or generic fingolimod at the pharmacy level.
Bioequivalence Studies
Fasted Study1
- Single center, randomized, single dose, laboratory blinded, single period, 3-treatment, 3-arm parallel study
- Test: TASCENSO ODT – 1 mg (2 x 0.5 mg ODT)
- Reference: Gilenya® – 1 mg (2 x 0.5 mg oral capsule)
- Treatment 1: 25 participants, single 1 mg dose of Test product, orally administered with 240 mL of water in the morning
- Treatment 2: 25 participants, single 1 mg dose of Test product, orally administered without water in the morning
- Treatment 3: 25 participants, single 1 mg dose of Reference product, orally administered with 240 mL of water in the morning
Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, with and without water, under fasting conditions

PK and Statistical Results
FINGOLIMOD PK Parameter |
TASCENSO ODT w/o water Geometric Mean Fasted |
Gilenya® w/ water Geometric Mean Fasted |
Geometric Mean Ratio (90% CI) target 80-125% |
---|---|---|---|
Tmax(h) (min-max) |
32.00 (10.00 – 58.87) |
28.00 (12.00 – 59.03) |
N/A |
Cmax(pg/mL) (SD) |
689.0 (96.1) |
761.6 (112.8) |
90.54 (84.64-96.98) |
AUC0-144(pg.h/mL) (SD) |
70875.8 (10224.8) |
77952.1 (12029.5) |
91.09 (84.66-98.01) |
FINGOLIMOD PK Parameter |
TASCENSO ODT w/ water Geometric Mean Fasted |
Gilenya® w/o water Geometric Mean Fasted |
Geometric Mean Ratio (90% CI) target 80-125% |
---|---|---|---|
Tmax(h) (min-max) |
32.00 (12.00 – 59.82) |
32.00 (10.00 – 58.87) |
N/A |
Cmax(pg/mL) (SD) |
722.7 (126.9) |
689.0 (96.1) |
104.33 (96.71-112.56) |
AUC0-144(pg.h/mL) (SD) |
74521.7 (15219.5) |
70875.8 (10224.8) |
104.19 (95.89-113.21) |
Fed Study1
- Single center, randomized, single dose, laboratory blinded, single period, 2-treatment, 2-arm parallel study
- Test: TASCENSO ODT – 1 mg (2 x 0.5 mg ODT) Reference: Gilenya® – 1 mg (2 x .5 mg oral capsule)
- Treatment 1: 19 participants, single 1 mg dose of Test product, orally administered without water under fed conditions
- Treatment 2: 19 participants, single 1 mg dose of Reference product, orally administered with 240 mL of water under fed conditions
Bioequivalence data of Gilenya® (fingolimod) capsules 0.5 mg and TASCENSO ODT® (fingolimod) orally disintegrating tablets 0.5 mg, under fed conditions

PK and Statistical Results
FINGOLIMOD PK Parameter |
TASCENSO ODT w/o water Geometric Mean Fasted |
Gilenya® w/ water Geometric Mean Fasted |
Geometric Mean Ratio (90% CI) target 80-125% |
---|---|---|---|
Tmax(h) (min-max) |
32.00 (6.00 – 59.70) |
32.00 (28.00 – 59.43) |
N/A |
Cmax(pg/mL) (SD) |
725.3 (105.6) |
760.1 (112.8) |
96.44 (88.07-103.44) |
AUC0-144(pg.h/mL) (SD) |
73410.6 (12275.8) |
79341.3 (14030.8) |
92.63 (84.63-101.73) |
Gilenya® is a registered trademark of Novartis AG.
References
1. Data on file: REF-00069.
2. FDA., 2022. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 3rd 2023. Available: www.accessdata.fda.gov/scripts/cder/ob/index.cfm