A Randomised, Partially Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE999302 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 multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval.
Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.

Start Date11 Jun 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

CTR20233819 / RecruitingPhase 3

一项随机、对照、评估者设盲、平行组、多中心试验，旨在比较10 μg或15 μg促卵泡激素δ（FE 999049）与150 IU或225 IU促卵泡激素α（果纳芬）在中国接受辅助生殖技术治疗的女性中作为控制性卵巢刺激常规方案起始剂量的卵巢反应

[Translation] A randomized, controlled, assessor-blinded, parallel-group, multicenter trial to compare ovarian response to 10 μg or 15 μg of follicle-stimulating hormone delta (FE 999049) versus 150 IU or 225 IU of follicle-stimulating hormone alfa (GONA-F) as a starting dose for routine controlled ovarian stimulation in Chinese women undergoing assisted reproductive technology.

在根据GnRH激动剂长方案接受控制性卵巢刺激的女性中，比较常规方案中起始剂量为10 μg或15 μg的FE 999049与起始剂量为150 IU或225 IU的果纳芬的卵巢反应

[Translation]

To compare the ovarian response of women undergoing controlled ovarian stimulation according to a long protocol with a GnRH agonist to a starting dose of 10 μg or 15 μg of FE 999049 versus a starting dose of 150 IU or 225 IU of GONAL-F in a conventional protocol

Start Date02 Apr 2024

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

[+3]

NCT06173869 / RecruitingPhase 3

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme in China

This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.

Start Date29 Mar 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

100 Clinical Results associated with Follitropin delta

100 Translational Medicine associated with Follitropin delta

100 Patents (Medical) associated with Follitropin delta

1,815

Literatures (Medical) associated with Follitropin delta

01 Apr 2024·Domestic animal endocrinology

Field outcomes of laparoscopic ovum pick-up combined with in vitro embryo production in sheep: Effects of long-acting recombinant ovine FSH pre-stimulation, collection frequency, and donor breed

Article

Author: An, Lei ; Chou, Chunjuan ; Yue, Yuan ; Chen, Dayong ; Song, Yukun ; Zhang, Jiaxin ; Cheng, Lei ; Zhang, Nan ; Tian, Jianhui

Laparoscopic ovum pick-up (LOPU) combined with in vitro embryo production (IVEP) is a technology platform that improves the utilization rate of the elite ewe's ovarian oocytes and increases the number of obtained offspring. This study aimed to evaluate the effects of FSH pre-stimulation, serial oocyte collection, and breed on LOPU-IVEP under field conditions. Donors were randomly assigned to five groups (group A: decreasing doses of pituitary FSH (p-FSH); group B: constant doses of p-FSH; group C: two doses of long-acting recombinant ovine FSH (ro-FSH); group D: single administration of a long-acting ro-FSH in; group E: no FSH stimulation). Oocyte yield following LOPU (average recovered oocytes: 20.9 ± 0.5; average viable oocytes: 17.2 ± 0.4) and oocyte developmental competence (average blastocysts: 7.0 ± 0.2) in group C were significantly better than these of group D and group E, and similar to these of groups A and B. Meanwhile, there were no differences in oocyte yield and developmental capacity using repeated LOPU session at 1-, 2-, and 3-month intervals (p > 0.05). Finally, we compared LOPU-IVEP outcomes among five sheep breeds. The results indicated that East Friesian × Chinese Mongolian crossbred sheep and purebred East Friesian sheep had the more recovered oocytes and viable oocytes compared with the Suffolk, Dorper, and Texel breeds, and average number of blastocysts in East Friesian × Chinese Mongolian sheep group was also highest among the groups (8.1 ±0.3, p < 0.05). In summary, the results of this study indicate long-acting ro-FSH pre-stimulation combined with 12 times LOPU sessions over one year maximizes embryo production of elite donor ewes under field conditions.

01 Mar 2024·European journal of obstetrics, gynecology, and reproductive biology

Oocyte competence is comparable between progestin primed ovarian stimulation with Norethisterone acetate (NETA-PPOS) and GnRH-antagonist protocols: A matched case-control study in PGT-A cycles

Article

Author: Alviggi, Carlo ; Maria Ubaldi, Filippo ; Carmelo, Ramona ; Alfano, Simona ; Rania, Erika ; Trabucco, Elisabetta ; Gallo, Cinzia ; Ruffa, Alessandro ; Pittana, Erika ; Fiorenza, Alessia ; Vaiarelli, Alberto ; Rosaria Campitiello, Maria ; Venturella, Roberta ; Rienzi, Laura ; Cimadomo, Danilo ; Alviggi, Erminia

OBJECTIVE:

To outline oocyte competence after progestin primed ovarian stimulation with Norethisterone acetate (NETA-PPOS) compared to conventional GnRH-antagonist protocol.

STUDY DESIGN:

Retrospective matched case-control study involving advanced-maternal-age women undergoing ICSI with PGT-A. 89 NETA-PPOS were matched with 178 control patients based on maternal age and ovarian reserve biomarkers. Both groups underwent recombinant-FSH OS with GnRH-agonist ovulation trigger and collected ≥1 MII. In the study group, NETA (10 mg/day) was administered orally starting from day2 of the menstrual cycle. Euploid blastocyst rate per cohort of metaphase-II oocytes (EBR per MII) was the primary outcome. All other embryological and clinical outcomes were reported. Gestational age, birthweight and length were also assessed.

RESULTS:

The EBR per MII was comparable among PPOS and control (13.9 % ± 19.3 % versus 13.3 % ± 17.9 %; the sample size allowed to exclude up to a 10 % difference). Blastocysts morphology and developmental rate were similar. No difference was reported for all clinical outcomes among the 61 and 107 vitrified-warmed euploid single blastocyst transfers respectively conducted. The cumulative live birth delivery rate per concluded cycles was also comparable (24.7 % versus 21.9 %). Neonatal outcomes were analogous.

CONCLUSIONS:

Oocyte competence after NETA-PPOS and standard OS is comparable. This evidence is reassuring and, because of its lower cost and possibly higher patients' compliance, supports PPOS administration whenever the patients are indicated to freeze-all (e.g., fertility preservation, PGT-A, oocyte donation). More data are required about follicle recruitment, oocyte yield, gestational and perinatal outcomes. Randomized-controlled-trials are advisable to confirm our evidence.

01 Feb 2024·European journal of obstetrics, gynecology, and reproductive biology

Prospective multicenter observational real-world study to assess the use, efficacy and safety profile of follitropin delta during IVF/ICSI procedures (DELTA Study)

Review

Author: Decanter, Christine ; Oger, Pierre ; Bry-Gauillard, Hélène ; Grynberg, Michaël ; Maignien, Chloé ; Bernot, Mathilde ; Guivarc'h-Levêque, Anne ; Swierkowski-Blanchard, Nelly ; Porcu-Buisson, Géraldine ; Barrière, Paul ; Hocké, Claude ; Rongières, Catherine ; Ranisavljevic, Noémie

OBJECTIVE:

To describe the use, efficacy and safety profile of follitropin delta in women undergoing IVF/ICSI in routine clinical practice after one treatment cycle.

STUDY DESIGN:

This was a French multicenter, prospective, observational study conducted in 14 fertility centers between June 2020 and June 2021. During this period, 248 women undergoing IVF or ICSI were treated with follitropin delta for the first time. Women were followed up to 10-11 weeks after the first fresh or frozen embryo transfer. The main outcomes were use of dosing algorithm, follitropin delta dosing patterns, ovarian response, pregnancy, and adverse drug reactions in routine clinical practice.

RESULTS:

The analyzable population consisted of 223 patients with mean ± SD age of 33.0 ± 4.4 years, body weight of 65.7 ± 11.8 kg, and the median (IQR) AMH level was 2.6 (1.5-4.0) ng/mL. For 193 patients (86.5 %) it was the first IVF/ICSI cycle and for 30 (13.5 %) the second. The algorithm was used for the calculation of the starting dose for 88.3 % of the patients. The mean daily starting dose of follitropin delta was 11.4 ± 4.1mcg for the whole analyzable population and 14.4 ± 5.2 mcg for the sub-group of 26 patients dosed without the algorithm. The mean duration of stimulation with follitropin delta was 10.8 ± 5.2 days. The mean total dose of follitropin delta administered was 122.2 ± 80.0 mcg. An antagonist protocol was used in 90.3 % of patients. The mean ± SD number of oocytes retrieved among patients that started stimulation was 11.3 ± 6.8 and 46.1 % of patients achieved the targeted response of the algorithm of 8-14 oocytes retrieved. A fresh transfer was performed for 77.6 % of patients; the mean ± SD number of embryos transferred was 1.3 ± 0.5. The implantation rate was 36.0 %. Per started cycle, clinical pregnancy was reported in 35.0 % of the patients and ongoing pregnancy in 29.6 %. In total, 5 patients (2.2 %) reported an event of OHSS.

CONCLUSION:

Clinical results as collected in routine clinical practice are promising, showing a favorable effectiveness-safety profile of follitropin delta for a very varied patient population (including anovulatory PCOS, very poor responders, or non-IVF naïve patients). These real-world data complement results from clinical trials and provide useful information for usual clinical practice within a heterogeneous population group.

News (Medical) associated with Follitropin delta

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
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.

to view more data

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	Phase 3	JP	Ferring Pharmaceuticals A/S	29 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03809429 (BEYOND, Pubmed)	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin delta	fzbwjioilz(whbqmvvera) = ibakoycywe jjqgfmdzwz (frxymzgktm ) View more	Positive	09 May 2024
				follitropin delta	fzbwjioilz(whbqmvvera) = ajgascefez jjqgfmdzwz (frxymzgktm ) View more
NCT03740737 (RITA-1, CTgov)	Phase 3	Infertility	579	Follitropin delta (FE 999049 (Follitropin Delta))	zcilyatvpc(fjuigituqw) = tfahrdxuyx iveejkveyu (qnidsatxvz, rlydnqbxeh - jhydvzjgfe) View more	-	18 Jan 2024
				Placebo (Placebo)	zcilyatvpc(fjuigituqw) = alrzaefqti iveejkveyu (qnidsatxvz, pwiajkmcfe - ggwsikfsao) View more
NCT03738618 (CTgov)	Phase 3	Infertility, Female	588	Follitropin delta	zkmwtkxbwm(qirbezdbjt) = rmxsfpknjs dylxxyhcjh (ujlxvbvrum, nujwmyfcgq - tijrmrtpxe) View more	-	18 Jan 2024
NCT04150861 (Pubmed)	Phase 1	-	24	Follitropin delta 12 μg	llyrfctucc(jpbkenjwhr) = xdwwtjlwiq mcnagglphk (lmvldistsj ) View more	-	07 Dec 2022
				Follitropin delta 18 μg	llyrfctucc(jpbkenjwhr) = rfbllglyll mcnagglphk (lmvldistsj ) View more
NCT03393780 (PROFILE, Pubmed)	Not Applicable	Ovarian Hyperstimulation Syndrome	944	Follitropin delta	oumfczswyj(xrlntbaehf) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) qjzuztgglp (urwptcyfky )	Positive	01 Jan 2022
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	Phase 3	-	800	follitropin delta (Japanese women)	ojwamjvhiw(kthqziauqn) = uaaqbnwyfb ehwfdnpxrc (kjswpfcuif )	-	23 Sep 2021
				follitropin delta (White women)	ojwamjvhiw(kthqziauqn) = kuboaobrfv ehwfdnpxrc (kjswpfcuif )
ESPE2021	Not Applicable	Hypogonadism	-	rFSH	okgyzquxmg(zrehaytbol) = ysxrifxtxr lucmmqfxdq (pmtexcgfts ) View more	-	22 Sep 2021
				hCG	bsnuowdtrd(gosggqlobe) = kowaokzynz rvqijxwihj (bslrjjxynu ) View more
NCT03296527 (Pubmed) Manual	Phase 3	-	1,009	follitropin delta	bzlaufutzi(lzhckmxzxa) = piacbxggfv oblhfhohgc (oipoimdjdi ) View more	Positive	18 Aug 2021
				follitropin alfa	bzlaufutzi(lzhckmxzxa) = mmgyllgssz oblhfhohgc (oipoimdjdi ) View more
NCT03296527 (GRAPE, CTgov)	Phase 3	Ovarian Hyperstimulation Syndrome	1,011	FE 999049 (FE 000049 (Follitropin Delta))	wxbyvfnvya(rjaedpeten) = dkzhrobpci lwmyfvgxtn (qfmydxcuyy, xjakijbrjm - jzgtxxluja) View more	-	01 Jun 2021
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	wxbyvfnvya(rjaedpeten) = iovyijelxk lwmyfvgxtn (qfmydxcuyy, qfbpqjxztt - zodiorpevk) View more
NCT03228680 (CTgov)	Phase 3	Infertility	373	FE 999049 (FE 999049 (Follitropin Delta))	wzdhojjlre(khcuitsbxc) = nunjxjbviu ajrzgenset (qfjarbvpvg, nixxiutdoq - kgmyoxmdax) View more	-	24 Mar 2021
				FOLLISTIM (FOLLISTIM (Follitropin Beta))	wzdhojjlre(khcuitsbxc) = jimsloatwe ajrzgenset (qfjarbvpvg, aeffzmyozx - jztptqjmvc) View more

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