tafoxiparin (DF01) / Dilafor - LARVOL DELTA

Priming of labor with tafoxiparin in nulliparous term pregnant women with unripe cervix-Proof-of-concept and dose-finding results from a randomized controlled trial. (PubMed, Acta Obstet Gynecol Scand) - P2 | "Tafoxiparin was effective in cervical ripening, facilitating spontaneous onset of labor and reducing the need for instrumental delivery. Benefits were most pronounced with the 300 mg dose, and a favorable safety profile was observed. These results suggest that tafoxiparin may be suitable for obstetrical use in outpatient and home-based settings."

Journal • Obstetrics

Tafoxiparin effects on cervical ripening and labour augmentation. (PubMed, Expert Opin Investig Drugs) - "Clinical evidence is still weak to generalize the results of the trials and support the introduction of the drug into daily medical practice, because few studies specifically focussing on this topic were published until now. In addition, many queries are left to be explored with future research, including optimal timing and doses, better route of administration, patient and physician acceptability, target pregnant populations and cost-effectiveness aspects."

Journal • Review • Obstetrics • Thrombosis

PPL24: A randomized, three-period, single-dose crossover trial in healthy female volunteers to demonstrate bioequivalence of tafoxiparin following subcutaneous administration via syringe/needle in the abdomen, and via an auto-injector in the abdomen and thigh, respectively. (clinicaltrialsregister.eu) - P1 | N=24 | Recruiting | Sponsor: Dilafor AB | Not yet recruiting ➔ Recruiting

Enrollment open

Cervical Glycosaminoglycans and Extracellular Matrix Remodeling: New Insights and the Therapeutic Promise of Tafoxiparin. (PubMed, Cells) - "Although tafoxiparin may replicate some actions of endogenous GAGs, current clinical data remain sparse and inconclusive. Thus, targeting cervical GAG biology represents a mechanistic yet still investigational strategy, requiring further studies to determine its therapeutic value."

Journal • Review • Cervical Cancer • Inflammation

Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies. (PubMed, Am J Obstet Gynecol) - "Subcutaneous treatment with tafoxiparin before labor onset (study 1) may be effective in reducing the labor time among women undergoing labor induction and among those requiring oxytocin for slow progression of labor. Moreover, tafoxiparin may have a positive effect on cervical ripening. Short-term, intravenous treatment with tafoxiparin as an adjunct to oxytocin in patients with labor arrest (study 2) did not affect labor time or other endpoints. Both studies suggest that tafoxiparin has a favorable safety profile in mothers and their infants."

Clinical • Journal • Review • Obstetrics

Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: a letter. (PubMed, Am J Obstet Gynecol) - No abstract available

Journal

Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from two randomized, placebo-controlled studies: A reply. (PubMed, Am J Obstet Gynecol) - No abstract available

Journal

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix (clinicaltrials.gov) - P2 | N=347 | Completed | Sponsor: Dilafor AB | Recruiting ➔ Completed | N=254 ➔ 347

Enrollment change • Trial completion

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix (clinicaltrials.gov) - P2 | N=254 | Recruiting | Sponsor: Dilafor AB | Trial completion date: Jun 2022 ➔ Jan 2023 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix (clinicaltrials.gov) - P2; N=254; Recruiting; Sponsor: Dilafor AB; Trial completion date: Jan 2022 ➔ Jun 2022; Trial primary completion date: Mar 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date

Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest (clinicaltrials.gov) - P2; N=361; Completed; Sponsor: Dilafor AB; Active, not recruiting ➔ Completed

Clinical • Trial completion

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix (clinicaltrials.gov) - P2; N=254; Recruiting; Sponsor: Dilafor AB; Trial completion date: Apr 2021 ➔ Jan 2022; Trial primary completion date: Apr 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date