Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

Start Date27 Aug 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

NCT06511791

/ RecruitingPhase 1

A Randomised, Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE 999302 When Administered During Different Time Intervals in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol.

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

Start Date15 Jul 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

CTIS2023-507630-25-00

/ RecruitingPhase 1

- 000426

Start Date21 Jun 2024

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

100 Clinical Results associated with Follitropin delta

100 Translational Medicine associated with Follitropin delta

100 Patents (Medical) associated with Follitropin delta

1,052

Literatures (Medical) associated with Follitropin delta

31 Mar 2025·African Journal of Reproductive Health

Efficacy and safety of simplified follitropin delta dosing in women undergoing intrauterine insemination in Indonesia

Article

Author: Halim, Binarwan ; Lubis, Hilma P ; Widjaja, Carine A

Available evidence indicate that Intrauterine Insemination (IUI) cycles with controlled ovarian stimulation (COS) yield better oocyte quality and higher pregnancy rates compared to those without COS in infertile women. As follitropin delta is an improved version of recombinant FSH, its ability to stimulate the development of multiple ovarian follicles is supposedly superior to follitropin alfa. The objective of this study was to evaluate the efficacy and safety of follitropin delta with a simplified dosage equivalent method in Indonesian women undergoing IUI. The design of this study was a retrospective observational study conducted from February 2022 to December 2023 involving 248 IUI cycles at Halim Fertility Center (HFC) IVF Center, Indonesia. Controlled Ovarian Stimulation was performed with follitropin delta with a simplified dosage equivalent method in IUI. From this study, we found that the clinical pregnancy rate (CPR) for IUI was 27.8%. The Ovarian Hyperstimulation Syndrome (OHSS) rates was 0.4%, with 2,9% multiple pregnancies in the follitropin delta with a simplified dosage equivalent method. This study showed no statistically significant differences in pregnancy rates based on age groups and BMI (p=0.288 vs p=0.934). WE conclude that follitropin delta may improve the outcome of intrauterine insemination in women undergoing IUI.

07 Mar 2025·Human Reproduction Open

Follicle-stimulating hormone stimulates free radical generation without inducing substantial oxidative stress in human granulosa cells

Article

Author: Schirhagl, Romana ; van Veen, Teelkien ; Li, Hui Ting ; Plosch, Torsten ; Lin, Jiazhe ; Lin, Nuan ; Groen, Henk ; van Zomeren, Koen C ; Hoek, Annemieke ; Cantineau, Astrid ; Hofsink, Naomi ; Zhou, Xiaoling ; Tietge, Uwe J F

Abstract:

STUDY QUESTION:

Does FSH induce free radical generation with substantial oxidative damage in human cumulus granulosa cells (cGCs) and mural granulosa cells (mGCs)?

SUMMARY ANSWER:

FSH of both physiological and supraphysiological concentrations induced free radical generation on subcellular levels, most notably in the mitochondria, while the elevated free radical load caused neglectable oxidative damage in both cGCs and mGCs.

WHAT IS KNOWN ALREADY:

FSH is fundamental for regulation of granulosa cell (GC) function and oocyte maturation, during which a physiological level of reactive oxygen species (ROS) is essential, while excessive amounts lead to oxidative damage. Potential adverse effects of high FSH doses on GCs may be mediated by ROS.

STUDY DESIGN, SIZE, DURATION:

This prospective experimental study included patients who attended a reproductive medicine center in 2023. cGC and mGC were separately isolated and brought into culture on the day of oocyte retrieval, 36 h after ovulation induction with recombinant hCG (250 mg). Recombinant FSH, at different concentrations, mimicking physiological (6 mIU/ml) and supraphysiological (60 and 600 mIU/ml) conditions, was applied (n = 4 in each group).

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Women aged 20–35 years, undergoing ICSI with at least three follicles, were included. Quantum sensing of cGC and mGC free radicals, detected by either cytoplasm-located fluorescent nanodiamonds (FNDs) or mitochondria-targeted FNDs, was tracked for 2 h following FSH treatment in a magnetometry setup. Mitochondrial function analysis, as well as oxidative damage to DNA/RNA, lipids, and proteins, upon FSH exposure, was examined.

MAIN RESULTS AND THE ROLE OF CHANCE:

FSH-induced cytoplasmic and mitochondrial ROS increases in cGC and mGC (P < 0.01 in all concentrations after 2 h) while showing different patterns along time: cGC showed significantly larger cytoplasmic ROS change compared with mGC to physiological (P < 0.01) and supraphysiological (P < 0.05) concentrations of FSH. Significantly larger free radical changes were observed in the mitochondria compared to the cytoplasm in response to FSH (all concentrations in cGCs with P < 0.05; supraphysiological concentrations in mGCs with P < 0.05, P < 0.001, respectively) after 2 h. Mitochondrial basal respiration and ATP production were significantly increased upon FSH exposure to supraphysiological concentrations in both cGCs (P < 0.01) and mGCs (P < 0.05). However, no oxidative damage to GC DNA/RNA, proteins, or lipids was found upon FSH exposure at any concentration except elevated lipid peroxidation in the FSH group of 600 mIU/ml (P < 0.05).

LARGE SCALE DATA:

N/A.

LIMITATIONS, REASONS FOR CAUTION:

The GCs came from females of different biological backgrounds and were stimulated before oocyte and GC retrieval, thereby increasing the risk of variation. In addition, the effects of long-term FSH exposure as well as the effects of the FSH-induced ROS on the oocyte remain to be investigated.

WIDER IMPLICATIONS OF THE FINDINGS:

We demonstrate that FSH of both physiological and supraphysiological concentrations induces free radical generation at subcellular levels, most notably in the mitochondria, while the elevated free radical load causes neglectable oxidative damage in both cGCs and mGCs. Our results suggest that the ‘FSH Ootoxicity’ hypothesis would not seem to be mediated by ROS in human GCs.

STUDY FUNDING/COMPETING INTEREST(S):

This study is supported by the Abel Tasman Talent Program (ATTP) of the Graduate School of Medical Sciences of the University Medical Center Groningen/University of Groningen, The Netherlands, as well as an XS grant from NWO. Unrelated to the current work, A.H. is a member of an advisory board on the development and application of a lifestyle App for patients with infertility from Ferring Pharmaceutical Company, The Netherlands. R.S. is the founder of QT Sense B.V., who commercialize quantum sensing equipment. This article has no direct relation to the work of QT Sense B.V. The remaining authors have no conflicts of interest.

04 Feb 2025·Cureus Journal of Medical Science

Letrozole Cotreatment Reduces Unexpectedly Poor Responses in Ovarian Stimulation With Follitropin Delta: A Strategy to Prevent High Anti-Müllerian Hormone (AMH) but Poor Response

Article

Author: Shindo, Mariko ; Yamada, Masayo ; Ishii, Kanako ; Koyama, Mika ; Kuroda, Hiromasa ; Murakami, Naoko ; Haruki, Atsushi ; Shibaike, Akiko ; Inukai, Kana ; Lee, Koichiro

BACKGROUND:

Follitropin delta is a novel recombinant follicle-stimulating hormone preparation used for in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). The dosage is determined using an original algorithm designed to achieve a target retrieval of 8-14 oocytes based on body weight and anti-Müllerian hormone (AMH) levels. However, unexpected poor responses, characterized by low oocyte retrieval numbers, occasionally occur in patients with high AMH levels who are otherwise expected to respond well. This study investigated whether cotreatment with letrozole reduces such poor responses.

METHODS:

A retrospective cohort study including 153 controlled ovarian stimulation (COS) cycles for IVF/ICSI using follitropin delta was performed at Haruki Ladies Clinic in Japan from October 2021 to March 2023. In total, 42 cycles were performed in the letrozole cotreatment group, and 111 cycles were performed in the group treated with follitropin delta alone. According to the concept of follitropin delta, seven or fewer oocytes retrieved were defined as a poor response.

RESULTS:

An unexpectedly poor response was observed at 6.0-6.9 µg daily doses of follitropin delta. The poor response was less frequent in the cotreatment group: one of 36 cycles (2.8%) in the cotreatment group and nine of 49 cycles (18.4%) in the follitropin delta alone group (p < 0.05). At daily doses of 7.0-11.9 μg, poor response was not often observed in both groups (0% vs. 3.6%). At 12.0 μg of daily dose, poor response frequently occurred in both groups. The duration of ovarian stimulation was decreased by cotreatment with letrozole (10.4 days vs. 8.7 days, p < 0.01). Letrozole cotreatment also reduced the total dosage of follitropin delta (65.2 µg vs. 53.3 µg, p < 0.01).

CONCLUSIONS:

Cotreatment with letrozole may reduce unanticipated suboptimal responses in patients expected to have good responses. Additionally, it may shorten the duration of ovarian stimulation and decrease the total dosage of follitropin delta required.

News (Medical) associated with Follitropin delta

10 Jul 2024

·www.globenewswire.com

FSH-free versus FSH-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized clinical trial

AMSTERDAM, July 10, 2024 (GLOBE NEWSWIRE) -- This randomized, controlled trial was conducted at a tertiary IVF center, Ho Chi Minh City, Vietnam. Between January 2023 and June 2023, 120 women were randomized. Eligible women were aged 18–37 years with polycystic ovarian syndrome (PCOS). After providing written informed consent, participants were randomized (1:1) to undergo CAPA-IVM with or without FSH-priming. Participants in the FSH-priming group received two days of recombinant FSH (rFSH) injections before oocyte pick-up; no rFSH was given in the non-FSH group. All retrieved cumulus oocyte complexes underwent biphasic in vitro maturation (CAPA-IVM). Matured oocytes underwent fertilization through ICSI procedure, and were cultured to blastocyst stage followed by vitrification. Participants underwent a single blastocyst transfer during a frozen replacement cycle. The primary endpoint was the number of matured oocytes. The number of matured oocytes after CAPA-IVM did not differ significantly between the non-FSH and FSH groups (13 [9; 18] vs. 14 [7; 18]; absolute difference –1 [95% confidence interval –5, 4]). There were also no significant between-group differences in other oocyte and embryology outcomes, including the number of cumulus-oocyte complexes, number of fertilized oocytes, total number of blastocysts and good blastocysts, and total number of frozen embryos. The live birth rate was 38.3% in the non-FSH group and 31.7% in the FSH group, with no statistically significant difference. The miscarriage rate at <12 weeks’ gestation was 5.0% in both groups. Maternal complications were infrequent and occurred at a similar rate in the non-FSH and FSH groups; there were no preterm deliveries before 32 weeks’ gestation. The study results were presented by Dr. Tuong M Ho at the 40th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) on July 9th, 2024 in Amsterdam (The Netherlands) and have been submitted for publication in a leading reproductive medicine journal. Prof Dr Lan Vuong from The University of Medicine and Pharmacy at Ho Chi Minh City and MyDuc hospital, HCMC, Vietnam, who led the study, said: “This randomized controlled trial with 120 patients proves that CAPA-IVM without rFSH priming is as effective as two days of rFSH priming. With a live birth rate of 38% for single blastocyst transfer CAPA-IVM achieved a similar live birth rate than standard IVF with 8-10 days of rFSH treatment. This is great news and a milestone achievement. The data supports our belief that women with PCOS are suitable for a complete gonadotrophin free, alternative fertility treatment.” About CAPA-IVM CAPA-IVM is a novel approach to in-vitro maturation of oocytes recovered after no or minimal ovarian stimulation, that incorporates a capacitation step in the maturation of oocytes in vitro which enhances oocyte developmental competence. CAPA-IVM is a patient-friendly assisted reproductive technology method that may become an alternative option to conventional ovarian stimulation and IVF, with reduced treatment burden in some selected groups of patients. The worldwide rights to the CAPA-IVM technology are owned by Lavima Fertility, Inc. Lavima Fertility is developing a medical device for future application of this technology. www.lavimafertility.com For more information:André Rosenthal andre.rosenthal@lavimafertility.comJohan Smitz johan.smitz@lavimafertility.com

Clinical ResultClinical Study

11 Apr 2023

·www.fiercebiotech.com

Ferring's research site closure signals shift from internal to external R&D, CSO says

Ferring Pharma's CSO says the company's commitment to reproductive and maternal health products is unchanged even as R&D priorities shift. After more than 25 years, Ferring Pharmaceuticals suddenly shuttered a San Diego research institute in March just months after finishing a major renovation. It's all part of the plan, says Chief Scientific Officer Armin Metzger, Ph.D. The research executive, now in his seventh year with Ferring, said that the company is making a concerted pivot toward external innovation to make the best use of capital following two FDA approvals at the end of 2022. It's a shift that Metzger describes as a "fundamental" change. "We will still have internal discovery, but [be] much, much more external focused, giving more flexibility of allocating funds," he said in an interview with Fierce Biotech. The clear-eyed assessment of the company’s priorities set the record straight as to why the Ferring Research Institute, one of the company’s three main R&D hubs, closed after 27 years. The move resulted in nearly 90 staffers being laid off and came after Ferring finished renovations on the institute just last year. “[T]he turning point was that we got two FDA approvals of two first-in-class assets in one year,” said Metzger. “And this leads to the adaptation, again of the strategy—how we deliver innovation to the patients—and it is not an easy decision-making process.” In November 2022, Ferring nabbed FDA approval for the first fecal microbiota product, Rebyota, for adults with C. difficile following antibiotic treatment or recurrent infection. Just a few weeks later, gene therapy Adstiladrin was approved for bladder cancer. The new strategy is not a complete departure from Ferring’s existing work, as those now-approved assets originated from deals. Ferring acquired Rebiotix in April 2018, tacking on the C. difficile treatments, and then a month later, the Swiss pharma signed a commercialization agreement with FKD Therapies for the bladder cancer treatment. “I think a company of our size, with the investment needed now on the later stage, we can't entertain technology platforms in-house,” said Metzger, who added that Ferring will instead rely on "partnerships across the globe.” Ferring’s main therapeutic areas are remaining unchanged, however, including maternal and reproductive health, which Metzger called “the core” of the company. One of the priorities is bringing the infertility treatment Rekovelle to the U.S. after it nabbed approval in Europe and Switzerland. He expects feedback from the FDA in the second half of the year. In addition to Rekovelle, infertility treatments LutrePulse and Menopur are under development, along with Pabal, a med for postpartum hemorrhage. But the clinical-stage work is in limbo. A phase 2 trial for a treatment to address inadequate milk production, merotocin, was shuttered earlier this year due to low enrollment and a phase 2 infertility treatment is now absent from the company’s pipeline. A spokesperson for Ferring did not immediately respond to a request for comment on the missing program. Regardless, Metzger says that in the next year, the company hopes to bolster its portfolio, including potentially boosting the indications for merotocin. This could also mean combination opportunities and female and male infertility assets from Ferring's reproductive medicine pipeline.

Drug ApprovalPhase 2AcquisitionGene TherapyLicense out/in

13 Mar 2023

·www.biospace.com

Ferring Announces Abstract of the First Prospective, Multi-National, Real-world Study of Rekovelle® (follitropin delta) at the Congress of the Pacific Society for Reproductive Medicine

PROFILE is the first prospective, multi-national, observational, real-world study of Rekovelle in clinical practice, conducted in more than 940 women from 10 countries across Europe, North America and Australia. This study provides evidence of the effectiveness of Rekovelle across a broad range of patients in a real-world clinical setting and supports its efficacy and safety profile, as previously demonstrated in randomised controlled trials (RCTs). 1-4 In the study, 74.0% of patients had between 4 and 19 oocytes retrieved and the ongoing pregnancy rates were similar to Phase 3 RCTs.1-3 Rekovelle is the only recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation (OS) that uses individualised dosing calculated through an approved algorithm based on bodyweight and anti-Müllerian hormone (AMH) levels. SAINT-PREX, Switzerland--(BUSINESS WIRE)-- Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia. The large, prospective, multi-national study confirms the effectiveness and safety of Rekovelle in routine clinical practice, with ongoing pregnancy rates similar to Phase 3 RCTs.1-3,5 The study was first published in Frontiers of Endocrinology in December 2022.5 The PROFILE study enrolled 944 women who had not previously undergone in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Results highlighted that with Rekovelle, almost three-quarters (74.0%) of women had between 4-19 oocytes retrieved and 255 women (27.0%) achieved an ongoing pregnancy at 10-11 weeks after transfer. The ongoing pregnancy rate was similar to the rates observed in the Phase 3 RCTs.1–3 The first cycle cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4%. The research also showed a 3.9% incidence of ovarian hyperstimulation syndrome (OHSS), with most cases of OHSS being of mild to moderate intensity, (n=30 [3.2%]) and all participants with OHSS made a full recovery.5 “Up to now, we have more than 2,000 patients in the RCTs for Rekovelle – ESTHER-1 and -2, GRAPE and STORK trials – but these had strict inclusion and exclusion criteria. Real-world data extends efficacy and safety data to all patients. In fact, in PROFILE there were nearly no restrictions other than that the participants were seeking to become pregnant, had no contraindications to rFSH, and had not previously undergone ovarian stimulation,” said Professor Christophe Blockeel, from Brussels IVF, the Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel and Vrije Universiteit Brussel, who was the principal investigator of the PROFILE study. In countries where it is licensed, Rekovelle is the only rFSH for OS that has an individualised fixed daily dose calculated using an approved algorithm based on bodyweight and levels of AMH. AMH is a biomarker used to predict ovarian response.6 In PROFILE, physicians used the Rekovelle dosing algorithm for nearly all participants (95%), although some made minor adjustments to the prescribed starting dose or adjusted the dose during OS based on clinical factors. Adverse drug reactions (ADRs) were monitored for all initiated OS cycles, and the number of ADRs leading to treatment and study discontinuation was low (n=4). “Ferring is committed to building healthy families of every shape and size by developing innovative fertility treatments. We are committed to seeking insights throughout the research and development of our treatments, so it is therefore encouraging to see that in an observational study of real-world clinical practice, Rekovelle confirmed its effectiveness through ongoing pregnancy rates, similar, or higher than RCTs,” said Christina Lloyd, Senior Vice President and Head of Reproductive Medicine and Maternal Health, Ferring Pharmaceuticals. - ENDS - About the PROFILE study In the PROFILE study (Prospective multicentre non-interventional study to assess the patterns of use of Rekovelle in women undergoing in vitrO Fertilisation or Intracytoplasmic sperm injection procedures in routine clinicaL practicE), 1,258 women were screened between March 2018 and October 2020, and 1,013 met the inclusion and exclusion criteria. A total of 944 participants initiated their first OS cycle at 34 specialist fertility clinics across Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain and UK in which Rekovelle is licensed. The primary endpoint was the real-world treatment patterns of follitropin delta, including starting daily dose, number of days of treatment, deviations from the approved dosing schedule as per the summary of product characteristics (per-label), use of dosing algorithm, and use of other treatments during OS, such as GnRH protocol, triggering methods of follicle maturation and luteal phase support. Secondary endpoints included cycle cancellations, pregnancy outcomes for Cycle 1, and OHSS and other ADRs for all initiated cycles. Participants could initiate up to three OS cycles with Rekovelle; however, utility and effectiveness data were only analysed for Cycle 1 as the study was terminated early due to the COVID-19 pandemic, during which many fertility clinics closed or provided reduced services. Real-World Utilisation Patterns of Rekovelle The study aimed to observe the real-world utilisation patterns, effectiveness, and safety pro follitropin delta in women ≥18 years naïve to OS undergoing IVF or ICSI. According to the data collected during the study, most participants received Rekovelle as specified in the approved label without dose deviations. In PROFILE, nearly all patients (95%) had their starting dose calculated using the algorithm, although some physicians then made minor adjustments to the prescribed starting dose during the OS cycle based on clinical factors. “We wanted to know if physicians are really using the dosing algorithm, and the answer is yes, the vast majority did. I think this really reflects how Rekovelle is being used in the real world and physicians are using the algorithm in those countries where it is approved,” said Professor Blockeel. In PROFILE, the mean total dose of follitropin delta was slightly higher than observed in randomised clinical trials, reflecting differences in bodyweight and AMH levels of the participants.1-5 The PROFILE study had no enrolment restrictions for bodyweight or AMH levels, and the overall study population had a higher mean bodyweight and had lower or comparable median AMH levels than the RCT cohorts.1-3,5 Adverse Drug Reactions ADRs were monitored for all initiated OS cycles (1,130 cycles for 944 participants). Forty-nine participants (5.2%) reported 58 ADRs. The number of ADRs leading to treatment and study discontinuation was low (four participants experiencing six ADRs: OHSS, n=2 events; vomiting, n=1 event; headache, n=1 event; rash, n=1 event and premature ovulation, n=1 event). The most frequent ADR was any grade of ovarian hyperstimulation syndrome (OHSS; n=37 [3.9%]), which was similar to the incidence of OHSS in the Rekovelle arm during the first cycle of the RCT ESTHER-1 (3.5%).1 In the PROFILE study, most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) and all participants with OHSS made a full recovery. About Rekovelle (follitropin delta) Rekovelle is a human rFSH with an approved dosing algorithm designed for a predictable ovarian response.7 It is the first rFSH derived from a human cell line (PER.C6® cell line). Rekovelle is structurally and biochemically distinct from other existing rFSH gonadotrophins.7, 8 Rekovelle is approved in certain markets for use in OS for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI. The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s AMH level and body weight.7-9 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.6 The Rekovelle dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.7 Rekovelle is not approved in all markets. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. Learn more at , or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube. References 1. Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-96 e4. PubMed PMID: 27912901. Epub 2016/12/04. 2. Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 3. Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 4. Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, et al. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. Epub 2018/12/14. 5. Blockeel C, Griesinger G, Rago R, Larsson P, Sonderegger YLY, Rivière S, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. 6. Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. PubMed PMID: 23394782. Epub 2013/02/12. 7. Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2016. Approved on 12 December 2016 and last updated on the EMA website in March 2022. Available from [Accessed March 2023]. 8. Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521. 9. Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40 e5. PubMed PMID: 25256937. Epub 2014/09/27. ### View source version on businesswire.com: Contacts For more information, please contact Amy Cheshire Director, Corporate Communications Amy.Cheshire@ferring.com Samara Barr Account Manager, Syneos Health Communications PR Europe +44 (0)7935 076261 (mobile) Samara.Barr@syneoshealth.com Source: Ferring Pharmaceuticals View this news release online at:

Phase 3Clinical ResultDrug Approval

100 Deals associated with Follitropin delta

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Infertility	Canada	Ferring, Inc.	22 Mar 2018
Infertility, Female	Australia	Ferring Pharmaceuticals Pty Ltd.	21 Sep 2017
Ovarian Stimulations	European Union	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Iceland	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Liechtenstein	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Norway	Ferring Pharmaceuticals A/S	12 Dec 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Female infertility of tubal origin	Phase 3	India	Ferring Pharmaceuticals A/S	03 Dec 2021
Infertility, Male	Phase 3	India	Ferring Pharmaceuticals A/S	03 Dec 2021
Ovarian Hyperstimulation Syndrome	Phase 3	China	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	South Korea	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	Taiwan Province	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	Vietnam	Ferring Pharmaceuticals A/S	01 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05103228 (CTgov)	Not Applicable	Infertility \| Ovarian Diseases	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	xyfvphoqav = xljyauowhn hkcgdxebcq (fkgxkbtver, uwxprbccfs - sufvmglzog) View more	-	13 Dec 2024
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	xyfvphoqav = yodqmahdkx hkcgdxebcq (fkgxkbtver, ifozhqxhyy - kyilmnsanc) View more
NCT03809429 (BEYOND, CTgov)	Phase 3	Infertility, Female	437	FE 999049 + GnRH agonist (GONAPEPTYL) (FE 999049 + GnRH Agonist (GONAPEPTYL))	iuwwezrued(wowlhupnbc) = urcteyeyze savuqxgtek (mbhljmfznv, 5.9) View more	-	13 May 2024
				FE 999049 + GnRH antagonist (CETROTIDE) (FE 999049 + GnRH Antagonist (CETROTIDE))	iuwwezrued(wowlhupnbc) = yvugvgvxav savuqxgtek (mbhljmfznv, 5.5) View more
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) Manual	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin delta (GnRH agonist protocol)	sofbbyoaut(kcufvdodrw) = wkfbnyytba bzyyorqbbg (riwzskxkbk, 5.9) View more	Positive	09 May 2024
				FE 999049follitropin delta (GnRH antagonist protocol)	sofbbyoaut(kcufvdodrw) = vvruqreeyp bzyyorqbbg (riwzskxkbk, 5.5) View more
NCT03740737 (RITA-1, CTgov)	Phase 3	Infertility	579	Follitropin delta (FE 999049 (Follitropin Delta))	fpwvvidktl = gbwkfzmmpm ajzjgxtyjf (bgxzgxteqa, quxjmjyajv - qqdizjbgba) View more	-	18 Jan 2024
				Placebo (Placebo)	fpwvvidktl = trrqtlcjrg ajzjgxtyjf (bgxzgxteqa, kyzkeeltts - rffjfqwpgm) View more
NCT03738618 (RITA-2, CTgov)	Phase 3	Infertility, Female	588	Follitropin delta (FE 999049 (Follitropin Delta))	ilzonzppgh = pldtcaitsz qyjqwxfuag (cnkbbbgqqf, bnfomeukwd - ubkzysueiq) View more	-	18 Jan 2024
				Placebo (Placebo)	ilzonzppgh = lcqyqtrawk qyjqwxfuag (cnkbbbgqqf, ubvuwjtapy - zqznexksnf) View more
NCT03564509 (Pubmed \| Reprod Biol Endocrinol)	Phase 2	serum anti-Müllerian hormone (AMH)	104	Follitropin delta in long GnRH agonist protocol	knkhgloqfk(lmiubljdqa) = 6 cases of early OHSS (5.8%) graded as mild (n = 3) and moderate (n = 3) ryjhqsurfl (snjemnylqr ) View more	Positive	16 May 2023
NCT03296527 (GRAPE, Pubmed)	Phase 3	-	759	Follitropin delta	acfainooee(pmtytaypvf) = ukibjidpkp vghdplygyz (qekrxenfst, -1.3 to 11.5) View more	Positive	04 Oct 2022
				Follitropin alfa	acfainooee(pmtytaypvf) = lyvfdhwamo vghdplygyz (qekrxenfst ) View more
ESPE2021	Not Applicable	Hypogonadism	-	rFSH	jwqlpmbkxn(miowlbrjub) = iawbjgnjpg knjsgqewfl (rdmrzqgimx ) View more	-	22 Sep 2021
				hCG	mgqstihyij(aamjsnxymt) = udrbsuwvwd xryjrawhbl (uurrnpbecd ) View more
NCT03296527 (Pubmed \| Hum Reprod) Manual	Phase 3	-	1,009	follitropin delta	eiacvfjati(plwrqvwcxh) = cbbxehengm gyumlsuumr (lcfxedyftv ) View more	Positive	18 Aug 2021
				follitropin alfa	eiacvfjati(plwrqvwcxh) = medzykefcc gyumlsuumr (lcfxedyftv ) View more
NCT03296527 (GRAPE, CTgov)	Phase 3	Ovarian Hyperstimulation Syndrome	1,011	FE 999049 (FE 000049 (Follitropin Delta))	sedreryyfs = eylrqevvkt jvrvvyhifr (vbqlxiewyg, hiwtlncqji - fyspfleuuh) View more	-	01 Jun 2021
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	sedreryyfs = smgcaujpae jvrvvyhifr (vbqlxiewyg, yhkxljflwm - guecnlobql) View more

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