TerSera Therapeutics

IL - Deerfield

Biotechnology

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Focus: Acquisition & Licensing

TerSera Therapeutics is a life sciences company focused on Acquisition & Licensing.

OncologyImmunologyNeurologyRespiratoryHematology

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2

Products & Portfolio (9)

5 discontinued products not shown

ergotamine tartrate

SUBLINGUAL · TABLET

CLINICAL PHARMACOLOGY: Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater. Pharmacokinetics: Interactions Pharmacokinetic interactions (increased blood levels of ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g., ritonavir) presumably due to inhibition of cytochrome P450 3A metabolism of ergotamine ( See ). Ergotamine has also been shown to be an inhibitor of cytochrome P450 3A catalyzed reactions. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known.

CLINICAL PHARMACOLOGY Pharmacodynamics Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of etodolac, like that of other NSAIDs, is not completely understood, but may be related to the prostaglandin synthetase inhibition. Etodolac is a racemic mixture of [-]R- and [+]S-etodolac. As with other NSAIDs, it has been demonstrated in animals that the [+]S-form is biologically active. Both enantiomers are stable and there is no [-]R to [+]S conversion in vivo . Pharmacokinetics Absorption The systemic bioavailability of etodolac from etodolac capsules and tablets is 100% as compared to solution and at least 80% as determined from mass balance studies. Etodolac is well absorbed and had a relative bioavailability of 100% when 200 mg capsules were compared with a solution of etodolac. Based on mass balance studies, the systemic availability of etodolac from either the tablet or capsule formulation is at least 80%. Etodolac does not undergo significant first-pass metabolism following oral administration. Mean (± 1 SD) peak plasma concentrations (C max ) range from approximately 14 ± 4 to 37 ± 9 μg/mL after 200 to 600 mg single doses and are reached in 80 ± 30 minutes (see for summary of pharmacokinetic parameters). The dose-proportionality based on the area under the plasma concentration-time curve (AUC) is linear following doses up to 600 mg every 12 hours. Peak concentrations are dose proportional for both total and free etodolac following doses up to 400 mg every 12 hours, but following a 600 mg dose, the peak is about 20% higher than predicted on the basis of lower doses. The extent of absorption of etodolac is not affected when etodolac tablets or capsules are administered after a meal. Food intake, however, reduces the peak concentration reached by approximately one-half and increases the time to peak concentration by 1.4 to 3.8 hours. Table 1. Mean (CV%) % Coefficient of variation Pharmacokinetic Parameters of etodolac in Normal Healthy Adults and Various Special Populations PK Parameters Normal Healthy Adults (18-65) Age Range (years) Healthy Males (18-65) Healthy Females (27-65) Elderly (>65) (70-84) Hemodialysis (24-65) (n=9) Renal Impairment (46-73) Hepatic Impairment (34-60) (n=179) (n=176) (n=3) Dialysis On Dialysis Off (n=10) (n=9) NA = not available T max , h 1.4 (61%) 1.4 (60%) 1.7 (60%) 1.2 (43%) 1.7 (88%) 0.9 (67%) 2.1 (46%) 1.1 (15%) Oral Clearance, mL/h/kg (CL/F) 49.1 (33%) 49.4 (33%) 35.7 (28%) 45.7 (27%) NA NA 58.3 (19%) 42.0 (43%) Apparent Volume of Distribution, mL/kg (Vd/F) 393 (29%) 394 (29%) 300 (8%) 414 (38%) NA NA NA NA Terminal Half-Life, h 6.4 (22%) 6.4 (22%) 7.9 (35%) 6.5 (24%) 5.1 (22%) 7.5 (34%) NA 5.7 (24%) Distribution The mean apparent volume of distribution (Vd/F) of etodolac is approximately 390 mL/kg. Etodolac is more than 99% bound to plasma proteins, primarily to albumin. The free fraction is less

Rheumatoid arthritis

ziconotide acetate

LOE Approaching

INTRATHECAL · INJECTABLE

telotristat ethyl

LOE Approaching

IMPLANTATION · IMPLANT

LOE Approaching

IMPLANTATION · IMPLANT

LOE Approaching

IMPLANTATION · IMPLANT

Pipeline & Clinical Trials

Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score

Prostate Cancer

N/A

Clinical Trials (1)

NCT05820633Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

N/A

Margetuximab

HER2-positive Breast Cancer

N/A

Clinical Trials (1)

NCT03133988Margetuximab Expanded Access Program

N/A

Xermelo

Carcinoid Syndrome

N/A

Clinical Trials (1)

NCT03223428Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

N/A

ZOLADEX

Advanced Breast Cancer

Phase 1

Clinical Trials (1)

NCT07310420A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Phase 1

Cetirizine HCl 10 mg/mL

Oncology Patients Receiving Chemotherapy

Phase 2

Clinical Trials (1)

NCT04189588Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

Phase 2

telotristat ethyl

Biliary Tract Cancer (BTC)

Phase 2

Clinical Trials (1)

NCT03790111A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer

Phase 2

Telotristat

Neuroendocrine Tumors

Phase 2

Clinical Trials (1)

NCT04543955Telotristat With Lutathera in Neuroendocrine Tumors

Phase 2

Open Jobs (2)

Key Account Manager

Institutional Account Manager

Interview Prep Quick Facts

Portfolio: 14 approved products, 7 clinical trials

Top TAs: Neurology, Immunology, Respiratory

Open Roles: 2 active jobs

Portfolio Health

Peak4 (29%)

LOE Approaching6 (43%)

Post-LOE4 (29%)

14 total products

Therapeutic Area Focus

2 marketed

1 marketed

1 marketed

Marketed

Pipeline

Hiring Trend

Stable

2

Open Roles

+0

Added

-0

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Based on last 4 crawl cycles