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 / Recruiting

- 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

1,836

Literatures (Medical) associated with Follitropin delta

01 Dec 2024·ARCHIVES OF MEDICAL RESEARCH

Follicle-stimulating hormone sweetness: How carbohydrate structures impact on the biological function of the hormone

Review

Author: Dias, James A. ; Dias, James A ; Ulloa-Aguirre, Alfredo ; Llamosas, Regina

Follicle-stimulating hormone (FSH), or follitropin, exists in multiple molecular forms due largely to its protein-carbohydrate composition and the complexity of the glycans attached to the protein core. The heterogeneity of gonadotropins exists in two forms, macroheterogeneity, which results from the absence of one or two oligosaccharide chains in the ß-subunit, and microheterogeneity which results from variation in the structures and complexity of the glycans attached to the hormone. In the clinical arena, FSH compounds are widely used by fertility specialists to promote ovarian follicle growth and maturation to a preovulatory follicle containing a fertilization-competent oocyte. Several genetically engineered recombinant human FSH preparations have been added to the arsenal of follitropin preparations in several countries for the treatment of infertility, particularly in women attending assisted reproduction clinics. Although the primary structure of these recombinant proteins is identical to that of naturally occurring FSH, the cell context and variations in the production and purification processes may impact the glycosidic profile of the recombinant FSH macro- and micro-heterogeneity, which may potentially influence the pharmacokinetics and pharmacodynamics of the compound. This review concentrates on the structure-function correlates of follitropin, with emphasis on the physiological and biological importance of the carbohydrates attached to its protein core, including its pharmacokinetics and biological activity. Emphasis is placed on pituitary FSH, and the available data on the various recombinant FSH preparations employed in therapeutics are also discussed, considering that this gonadotropin represents the cornerstone for the treatment of infertility in modern assisted reproduction.

01 Dec 2024·Reproductive Biology

HLA-DQB1 as a potential prognostic biomarker of hormonal therapy in patients with non-obstructive azoospermia

Article

Author: Berger, Anna ; Rozwadowska, Natalia ; Jedrzejczak, Piotr ; Malcher, Agnieszka ; Wolski, Jan Karol ; Kamieniczna, Marzena ; Stokowy, Tomasz ; Kurpisz, Maciej

The gonadotropin treatment of infertile men may improve spermatogenesis and lead to sperm cell production, however, only a small fraction of treated patients positively responds to such therapy. To identify individual treatment prognostic biomarkers associated with responsiveness to gonadotropins, we compared the gene expression profiles of testicular oligobiopsies from 3 patients with non-obstructive azoospermia (NOA) who positively responded to therapy with a combination of human chorionic gonadotropin and recombinant follicle-stimulating hormone (hCG/rFSH) to those of 3 non-responders. We used Affymetrix Human Gene 1.0 ST microarrays. The results of the microarray evaluation were validated by the qPCR technique while gene variants of the HLA-DQB1 (major histocompatibility complex, class II, DQ beta 1) were subsequently sequenced. In our microarrays, we have identified most significantly 5 transcripts with different expression levels in responders versus non-responders groups. Our interest has been primarily focused on the transcript associated with the HLA-DQB1 gene. Because the expression of this gene was up-regulated in the non-responding patients and only patients with heterozygotic alleles of HLA-DQB1 turned out to be positive to gonadotropin therapy, we suggest that this gene may be a biomarker of potential significance for the gonadotropin treatment of male infertility. We also compared the testicular gene expression profile in one individual before and after gonadotropin treatment. In the re-biopsied sample, we have identified over 600 genes that showed differences in testicular expression; some of these genes are critical for spermiogenesis. Thus, we documented that the applied gonadotropins successfully stimulated the spermatogenetic wave in patients with NOA.

01 Oct 2024·HUMAN REPRODUCTION

Undetected, natural conception pregnancies in luteal phase stimulations—case series and review of literature

Article

Author: Ata, B ; Lawrenz, B ; Fatemi, H ; Del Gallego, R ; Edades, J ; Kalafat, E ; Selim, S

Abstract:

STUDY QUESTION:

What is the risk of an undetected natural conception pregnancy during luteal phase ovarian stimulation, and how does it impact the pregnancy's course?

SUMMARY ANSWER:

The risk for an undetected, natural conception pregnancy in luteal phase ovarian stimulation is low and it appears that ovarian stimulation is unlikely to harm the pregnancy.

WHAT IS KNOWN ALREADY:

Random start ovarian stimulation appears to be similarly effective as early follicular stimulation start; and it allows ovarian stimulation to be started independent of the cycle day and throughout the cycle, in accordance with the patients’ and clinics’ schedule as long as there is no intention of a fresh embryo transfer in the same cycle. Starting ovarian stimulation in the luteal phase bears the possibility of an—at the timepoint of stimulation start—undetected, natural conception pregnancy that has already occurred. There is scarce data on the incidence of this event as well as on the possible implications of ovarian stimulation on the course of an existing pregnancy.

STUDY DESIGN, SIZE, DURATION:

This retrospective observational study, performed between June 2017 and January 2024, analyzed luteal phase stimulations, in which a natural conception pregnancy was detected during the ovarian stimulation treatment for IVF/ICSI. Luteal phase stimulation was defined as ovarian stimulation started after ovulation and before the next expected menstrual bleeding, with a serum progesterone (P4) level of >1.5 ng/ml on the day of stimulation start or 1 day before.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Women who underwent a luteal phase ovarian stimulation in a tertiary referral ART center.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 488 luteal phase stimulation cycles were included in the analysis. Luteal phase stimulation was only started after a negative serum hCG measurement on the day or 1 day before commencement of ovarian stimulation. Ten patients (2.1%) had an undetected natural conception pregnancy at the time of luteal phase stimulation start. Eight of these patients underwent an ovarian stimulation in a GnRH-antagonist protocol and two in a progestin-primed stimulation protocol (PPOS). Recombinant FSH was used as stimulation medication for all patients, the patients with a PPOS protocol received additional recombinant LH. One pregnancy (0.2%) was detected after the oocyte retrieval, the other nine pregnancies were detected either due to persistent high serum progesterone levels or due to an increasing progesterone level after an initial decrease before oocyte retrieval. In the cycles with an undetected natural conception pregnancy, the median number of stimulation days was 8 days (range: 6–11 days) and median serum hCG at detection of pregnancy was 59 IU hCG (range: 14.91–183.1). From 10 patients with a pregnancy, three patients delivered a healthy baby, two patients had ongoing pregnancies at the time of summarizing the data, three patients had biochemical pregnancies (patient age: 30, 39, and 42 years), one patient had an ectopic pregnancy which required a salpingectomy, and one patient (age: 34 years) had an early pregnancy loss.

LIMITATIONS, REASONS FOR CAUTION:

The retrospective study design and the small sample size can limit the accuracy of the estimates.

WIDER IMPLICATIONS OF THE FINDINGS:

Overall, there is a small risk of undetected natural conception pregnancies when luteal phase stimulation is undertaken. It appears that there are no adverse effects through either direct effect on the embryo or indirectly through a detrimental effect on the corpus luteum function on the pregnancy in our cohort.

STUDY FUNDING/COMPETING INTEREST(S):

This study did not receive funding. The authors declare that there is no conflict of interest.

TRIAL REGISTRATION NUMBER:

N/A.

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
-	-	G03GA10	DB00066

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Infertility, Female	CN	Ferring Pharmaceuticals A/S	30 Apr 2024
Infertility	CA	Ferring, Inc.	22 Mar 2018
Ovarian Stimulations	EU	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	IS	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	LI	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	NO	Ferring Pharmaceuticals A/S	12 Dec 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Hyperstimulation Syndrome	Phase 3	CN	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	KR	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	TW	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	VN	Ferring Pharmaceuticals A/S	01 Dec 2017
Infertility, Male	Phase 2	US	Ferring Pharmaceuticals A/S	16 Aug 2022
Infertility, Male	Phase 2	BE	Ferring Pharmaceuticals A/S	16 Aug 2022
Infertility, Male	Phase 2	DK	Ferring Pharmaceuticals A/S	16 Aug 2022
Infertility, Male	Phase 2	DE	Ferring Pharmaceuticals A/S	16 Aug 2022
Infertility, Male	Phase 2	IT	Ferring Pharmaceuticals A/S	16 Aug 2022
Infertility, Male	Phase 2	ES	Ferring Pharmaceuticals A/S	16 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03809429 (BEYOND, CTgov)	Phase 3	Infertility, Female	437	FE 999049 + GnRH agonist (GONAPEPTYL) (FE 999049 + GnRH Agonist (GONAPEPTYL))	swxnkvfzpu(ikoncfrpuh) = gsgtzdvika breqhzippe (onegkzgcpx, kwsiwjamsn - uheqxltehk) View more	-	13 May 2024
				FE 999049 + GnRH antagonist (CETROTIDE) (FE 999049 + GnRH Antagonist (CETROTIDE))	swxnkvfzpu(ikoncfrpuh) = pynikuwmeu breqhzippe (onegkzgcpx, bepgfxdmmz - wbyvenpanc) View more
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) Manual	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin deltaTYL	mxlncjwwbm(baauasuisn) = sggsbriduk jnfrbesqjb (kkqubsvvfm, 5.9) View more	Positive	09 May 2024
				FE 999049follitropin deltaDE	mxlncjwwbm(baauasuisn) = rdgrraekbu jnfrbesqjb (kkqubsvvfm, 5.5) View more
NCT03740737 (RITA-1, CTgov)	Phase 3	Infertility	579	Follitropin delta (FE 999049 (Follitropin Delta))	huicgqjvov(fyhagloebn) = thvzkewreu udnvqbywom (nrrxuzlbwx, exqsebwfcr - ambavtprkn) View more	-	18 Jan 2024
				Placebo (Placebo)	huicgqjvov(fyhagloebn) = stvhcuapcv udnvqbywom (nrrxuzlbwx, noaknaievz - lndotkzxxv) View more
NCT03738618 (RITA-2, CTgov)	Phase 3	Infertility, Female	588	Follitropin delta (FE 999049 (Follitropin Delta))	wvtnkowjjh(dragzriqfo) = ngwyxjeijr uodandgolx (czclbbiiav, ofncvrkaaa - xspsoqzshj) View more	-	18 Jan 2024
				Placebo (Placebo)	wvtnkowjjh(dragzriqfo) = fhzirnwbqu uodandgolx (czclbbiiav, jhianniuop - ewihirpyiu) View more
NCT03564509 (Pubmed \| Reprod Biol Endocrinol)	Phase 2	serum anti-Müllerian hormone (AMH)	104	Follitropin delta in long GnRH agonist protocol	hlxnqinrhi(opdjlszmpr) = 6 cases of early OHSS (5.8%) graded as mild (n = 3) and moderate (n = 3) trntucghgw (ylscyfqfdx ) View more	Positive	16 May 2023
NCT04150861 (Pubmed)	Phase 1	-	24	Follitropin delta 12 μg	kudeitporm(oejerkbttp) = mmezfammbw ykukrcgwhz (fymdwresvw ) View more	-	07 Dec 2022
				Follitropin delta 18 μg	kudeitporm(oejerkbttp) = ftefnxelbd ykukrcgwhz (fymdwresvw ) View more
NCT03393780 (PROFILE, Pubmed)	Not Applicable	Ovarian Hyperstimulation Syndrome	944	Follitropin delta	udnqnewdto(nwqysbxzdv) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) mpgdunibwz (uhwhtabjvl )	Positive	01 Jan 2022
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	Phase 3	-	800	follitropin delta (Japanese women)	ksqiogasgy(mzoubiyyri) = huwtsvgusa envwtejipt (cpcadkmhit )	-	23 Sep 2021
				follitropin delta (White women)	ksqiogasgy(mzoubiyyri) = nyxyasdptv envwtejipt (cpcadkmhit )
ESPE2021	Not Applicable	Hypogonadism	-	rFSH	jganapkxfk(rpfopiqrlq) = woqapbwvwv yzsvpbpgwu (zcwhfybsfo ) View more	-	22 Sep 2021
				hCG	lhflmousvu(rdxfxaxtvm) = mgtdeugcnp zkfrnubkju (dtczrkzife ) View more
NCT03296527 (Pubmed) Manual	Phase 3	-	1,009	follitropin delta	gcqixvrdrm(zokpwopvzo) = vkqjtzegza biwufvsbeq (nrncljjgdn ) View more	Positive	18 Aug 2021
				follitropin alfa	gcqixvrdrm(zokpwopvzo) = zadzqhbyxj biwufvsbeq (nrncljjgdn ) View more

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