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Last update 08 May 2025

SocraMetrics GmbH

Private Company

Last update 08 May 2025

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Translational Medicine

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Clinical Trials associated with SocraMetrics GmbH

NCT06866613

/ RecruitingPhase 3

Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of an Esflurbiprofen Topical System (EFTS) vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Ankle Sprains.

This study is a multi-center, double-blind, randomized controlled trial to evaluate the efficacy and safety of EFTS vs. placebo in patients with ankle sprains. The primary objective of this study is to demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with ankle sprains.
The secondary objective is to evaluate tolerability, local tolerability, and adhesion of EFTS vs. placebo.

Start Date31 Mar 2025

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+4]

NCT06870422

/ CompletedPhase 1

A Randomized, Four-way Change-over Study to Evaluate the Effect of Moderate Heat, Occlusion, and Moderate Exceise on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System in Healthy Volunteers

This study is a single-center, open-label, single-dose trial performed in a randomized, four-way, change-over design in healthy volunteers. The primary purpose of this study is to evaluate the effect of moderate heat, occlusion, and moderate exercise on pharmacokinetics. The secondary purpose is to characterize the effect of special conditions on the bioavailability and to evaluate patch adhesion and safety of TK-254RX and a residual amount of the patch.

Start Date28 Feb 2025

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+3]

NCT06871046

/ RecruitingPhase 3

An Open-label, Multi-centric Trial to Assess the Safety and Efficacy of an Esflurbiprofen Topical System (EFTS) in the Local Symptomatic and Short-term Treatment of Pain in Contusions.

This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.

Start Date20 Feb 2025

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+4]

100 Clinical Results associated with SocraMetrics GmbH

0 Patents (Medical) associated with SocraMetrics GmbH

Literatures (Medical) associated with SocraMetrics GmbH

01 Mar 2025·Fertility and Sterility

Inhibition of ovulation and pharmacologic mechanism of action of relugolix combination therapy

Article

Author: Klipping, Christine ; Draeger, Corinna ; Li, Yulan ; Duijkers, Ingrid J M ; Wedemeyer, Ralph-Steven ; Arjona Ferreira, Juan Camilo ; Migoya, Elizabeth M ; Schug, Barbara S

OBJECTIVETo assess the effects of relugolix combination therapy (CT) on ovarian function in healthy, ovulatory, premenopausal women.DESIGNThis was an open-label, single-cohort, pharmacodynamic, safety, and tolerability study consisting of five study periods: a pretreatment period to confirm ovulatory status, three 28-day treatment periods, and a posttreatment period to assess the duration of time required to return to ovulation after treatment discontinuation. Ovarian function was assessed by transvaginal ultrasonography and serum hormone concentrations.SUBJECTSHealthy, premenopausal female participants, 18-35 years of age.EXPOSURERelugolix CT (relugolix 40 mg, with estradiol 1 mg and norethindrone acetate 0.5 mg) was taken orally once daily for 84 days.MAIN OUTCOME MEASURESThe primary endpoint was the proportion of women in whom ovulation was inhibited during the 84-day treatment period. Secondary endpoints included proportion of women in whom ovulation was inhibited within each treatment period, number of women who fulfilled the Landgren criterion; characterization of follicular diameter, hormone concentrations, and endometrial thickness; time to return to ovulation after treatment discontinuation; proportion of women who returned to ovulation within 36 days after treatment discontinuation; safety and tolerability.RESULTSSeventy women were enrolled in the study, 67 of whom completed treatment. Treatment with relugolix CT inhibited ovulation in 100% of women who completed treatment (95% confidence interval, 94.6-100.0). Systemic concentrations of luteinizing hormone and follicle-stimulating hormone were suppressed and maintained at low concentrations during treatment, with an absence of a preovulatory luteinizing hormone surge. Median estradiol concentrations across all women were consistently maintained between 36.8 and 39.1 pg/mL (range, 12.1-121.1 pg/mL) during treatment. All individual progesterone concentrations during treatment remained below 1.57 ng/mL (5 nmol/L). After treatment discontinuation, all women ovulated or initiated menses. The mean time to return to ovulation was 23.5 days. Treatment was generally well tolerated with no safety or tolerability issues identified.CONCLUSIONRelugolix CT inhibits ovulation, which, in the context of this study, was achieved within the first cycle after treatment initiation. The rapid and predictable return of ovarian activity and ovulation after treatment discontinuation is advantageous for patients who wish to conceive thereafter.

01 Jun 2022·Contraception

Effect on ovarian activity and ovulation inhibition of different oral dosages of levonorgestrel

Article

Author: Klipping, Christine ; Rautenberg, Tanja ; Osterwald, Hermann ; Duijkers, Ingrid J M ; Schug, Barbara S ; Oettel, Michael ; Kochhar, Prithi S

OBJECTIVESTo investigate the effect of different oral dosages of levonorgestrel (LNG) on ovarian activity and to identify the lowest dosage at which no ovulation occurred. Secondary objectives were to assess return of ovulation after stopping treatment, bleeding pattern, pharmacokinetic (PK) parameters and safety and tolerability.STUDY DESIGNA parallel-group study with adaptive design was performed in 90 healthy women with proven ovulatory cycles. Investigated dosages were LNG 0.095, 0.115 and 0.135 mg per day. Measurements of follicular growth and estradiol (E₂) and progesterone concentrations were performed every 3 (±1) days during a 56-day treatment and a post-treatment period. Follicle-stimulating hormone and luteinizing hormone concentrations and multiple-dose PK parameters were determined during treatment.RESULTSTwo normal ovulations occurred in the LNG 0.095 mg group, none in the higher dose groups. Most subjects had active follicle-like structures without ovulation (Hoogland-Skouby scores 4). Ovarian activity was more suppressed in the highest dose group than in the other groups. Mean E₂ concentrations were 241, 219 and 180 pmol/L during treatment with 0.095, 0.115 and 0.135 mg per day, respectively. PK results showed dose-proportionality. Most subjects ovulated during the post-treatment period.CONCLUSIONLNG 0.115 mg per day was the lowest effective dosage for consistent ovulation inhibition. All investigated dosages were safe and well-tolerated, and mean E₂ concentrations were sufficient for prevention of hypoestrogenic side effects.IMPLICATIONSMarketed progestogen-only pills (POP) containing 0.03 mg LNG do not consistently inhibit ovulation. Increasing the dosage to 0.115 mg or 0.135 mg per day, resulting in consistent ovulation inhibition, may improve the contraceptive efficacy of the LNG-POP.

01 Jan 2021·ERJ Open Research

First clinical trials of the inhaled epithelial sodium channel inhibitor BI 1265162 in healthy volunteers

Article

Author: Mackie, Alison ; Endriss, Verena ; Rascher, Juliane ; Schmid, Marion ; Seibold, Wolfgang ; Brand, Tobias

BackgroundInhibition of the epithelial sodium channel (ENaC) represents a mutation-agnostic therapeutic approach to restore airway surface liquid hydration and mucociliary clearance in patients with cystic fibrosis. BI 1265162 is an inhaled ENaC inhibitor with demonstrated preclinical efficacy.MethodsThree phase I trials of BI 1265162 in healthy male subjects are presented:NCT03349723(single-rising-dose trial evaluating safety, tolerability and pharmacokinetics (PK));NCT03576144(multiple-rising-dose trial evaluating safety, tolerability and PK); andNCT03907280(absolute bioavailability trial).ResultsBI 1265162 single doses ≤1200 µg and multiple doses of 600 µg were well tolerated. Adverse events were balanced across treatment groups, were of mainly mild or moderate intensity and resolved by trial-end. One subject discontinued from trial medication on day 7 (asymptomatic hyperkalaemia adverse event; recovered day 8). One subject experienced a serious adverse event (neuropathia vestibularis) leading to hospitalisation and missed one of the four dosing periods. Both events were not considered to be drug-related and subjects recovered. BI 1265162 displayed dose-proportional, time-independent PK; maximum accumulation was 1.6-fold; calculated effective elimination half-life was 3.6–8.7 h over the dose ranges tested. Renal excretion was not a major drug elimination route. Oral and inhaled dosing (±activated oral charcoal) absolute bioavailability was 0.50% and ∼40%, respectively.ConclusionBI 1265162 single or multiple doses up to 6.5 days were well tolerated. Systemic exposures mainly represent drug absorbed through the lungs and not the gastrointestinal tract, with ∼40% of the inhaled dose reaching the systemic circulation. Accumulation was minimal. Twice-daily dosing is supported for future development.

100 Deals associated with SocraMetrics GmbH

100 Translational Medicine associated with SocraMetrics GmbH

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