Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.

Start Date01 Sep 2025

Sponsor / Collaborator

Centre Hospitalier Intercommunal Créteil

[+1]

NCT06997900

/ RecruitingPhase 2

Menopur And Rekovelle Combination Study Version 2.0

The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is:
- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ?
Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes
Participants will:
* Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight
* Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels
* Undergo standard IVF procedures including egg retrieval and embryo assessment

Start Date04 Jul 2025

Sponsor / Collaborator

Clinique Ovo, Inc.

[+1]

NCT06561958

/ RecruitingNot Applicable

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

100 Clinical Results associated with Follitropin delta

100 Translational Medicine associated with Follitropin delta

100 Patents (Medical) associated with Follitropin delta

1,173

Literatures (Medical) associated with Follitropin delta

01 Oct 2025·CLINICAL PHARMACOLOGY & THERAPEUTICS

The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis

Review

Author: Wang, Rui ; Stocker, Sophie L. ; Vollenhoven, Beverley J. ; Grosser, Mark ; Kirubakaran, Ranita ; Michael, Toni J.F. ; Parab, Tanay ; Smith, Vinayak

Understanding the variability in ovarian response following administration of follicle‐stimulating hormone medications in women undergoing in vitro fertilization may help inform prescribing decisions. A systematic review was conducted to compare the number of retrieved oocytes and fertility outcomes following the administration of different follicle‐stimulating hormone medications. Databases were searched from inception to November 2024, including studies that compared two follicle‐stimulating hormone medications, including follitropin alfa, follitropin beta, follitropin delta, and urofollitropin. Meta‐analyses were performed in random effects models with the restricted maximum likelihood method. From 3867 identified articles, 26 (12613 participants) were included. More oocytes were retrieved with follitropin alfa compared to beta (mean difference 0.64, 95% CI 0.09–1.19). Compared to follitropin delta, more oocytes were retrieved with follitropin alfa and beta (1.38, 95% CI 0.09–2.67, and 1.40, 95% CI 0.41–2.39, respectively); however, higher total doses of follitropin alfa and beta were administered (199.29 IU, 95% CI 43.15–355.43 and 181.08 IU, 95% CI 55.67–306.49, respectively), and the risk of hyperstimulation increased (risk ratios 1.42, 95% CI 1.04–1.96 and 1.75, 95% CI 1.15–2.70, respectively). More oocytes were retrieved with urofollitropin compared to follitropin beta (1.12, 95% CI −1.63 to −0.62), with higher total doses of urofollitropin administered (782.32 IU, 95% CI −1493.79 to −70.85). Variability in ovarian response and hyperstimulation rates across the medications decreased when similar total doses were administered. Fertilization, pregnancy, and live birth rates were similar across the medications, despite differences in the number of retrieved oocytes. Additional research is required to evaluate oocyte quality across follicle‐stimulating hormone medications.

01 Sep 2025·HUMAN REPRODUCTION

Ovarian stimulation with follitropin delta for in vitro fertilization: a multicentre, randomized, assessor-blind comparison with follitropin alfa using conventional dosing regimens (ADAPT-1 trial)

Article

Author: García Sánchez, Marta ; Jirecek, Stefan ; Bernabeu, Andrea ; Agrawal, Rina ; Lobo, Rita ; Zajc, Philipp ; Jepsen, Ida Engberg ; Papaleo, Enrico ; Møgelmose, Signe

Abstract:

STUDY QUESTION:

How do ovarian responses using conventional dosing for follitropin delta 15 µg/day compare with follitropin alfa 225 IU/day in women undergoing ovarian stimulation?

SUMMARY ANSWER:

The ADAPT-1 trial demonstrates similar ovarian responses with follitropin delta 15 µg/day and follitropin alfa 225 IU/day starting doses in a conventional dosing regimen.

WHAT IS KNOWN ALREADY:

Follitropin delta, a recombinant FSH (rFSH), is currently approved for ovarian stimulation using an individualized fixed daily dose based on serum anti-Müllerian hormone (AMH) and bodyweight (maximum 12 µg/day for first cycle and 24 µg/day in subsequent cycles). Other rFSHs, such as follitropin alfa, conventionally apply a starting dose of 150–225 IU, fixed for the initial days of stimulation, after which dose adjustments can be made (maximum 450 IU/day). Ovarian stimulation with follitropin delta 10 µg/day provides a similar ovarian response to follitropin alfa 150 IU/day for serum concentration and number of follicles ≥12 mm.

STUDY DESIGN, SIZE, DURATION:

ADAPT-1 was a randomized, accessor-blinded, multicentre trial comparing efficacy and safety of a starting dose of follitropin delta 15 µg/day with follitropin alfa 225 IU/day in conventional dosing regimens. The primary endpoint was the number of oocytes retrieved; mean difference between treatment groups was estimated using a negative binomial regression model (treatment and serum AMH level as factors). During the follow-up period, clinical pregnancies resulting from the first fresh/frozen transfers within 3 months of the start of stimulation, and ovarian hyperstimulation syndrome (OHSS) rates were assessed.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Participants, 18–40 years, undergoing IVF/ICSI could enrol at specialist reproductive clinics in Austria, France, Italy, Spain, and the United Kingdom for ovarian stimulation if they had no contraindications for treatment with a starting gonadotropin dose of 225 IU/day. Patients could enrol if they reported infertility for at least 1 year if ≤37 years and at least 6 months for those >37 years, and regular menstrual cycles (21–35 days). All cycles used a GnRH antagonist protocol.

MAIN RESULTS AND THE ROLE OF CHANCE:

Between 1 August 2022 and 16 April 2024, 300 of 337 screened patients were randomized to, and received, follitropin delta (n = 200) or follitropin alfa (n = 100). The two treatment groups were comparable in terms of demographics, baseline characteristics, and duration of infertility. The mean duration of treatment was ∼9 days in both groups. The mean total dose of follitropin delta was 143.7 ± 33.6 µg and 154.3 ± 23.1 µg (2105 ± 315 IU) for follitropin alfa. Three-quarters (226/300) used an human Chorionic Gonadotropin trigger for final follicular maturation. A mean of 9.9 oocytes was retrieved for both groups (estimated difference: 0.0 oocytes; 95% CI −1.3, 1.2). The category of 8–14 oocytes retrieved was the most common ovarian response (follitropin delta: 45.5%; follitropin alfa: 50.0%). Clinical pregnancy rates were comparable (31.6% and 31.0%; estimated difference 0.6 (95% CI −10.6, 11.8)). Early OHSS (≤9 days after triggering) occurred in 2.5% and 3.0%, and all cases were Grade 3 (moderate) or lower. No participant had the stimulation cycle cancelled due to excessive ovarian response.

LIMITATIONS, REASONS FOR CAUTION:

Only pregnancies from the first fresh or cryopreserved transfer within 3 months of oocyte retrieval were recorded. Cumulative pregnancy rates after the first transfer were not followed up. All analyses are of descriptive nature and no formal hypothesis testing or multiplicity adjustment was applied.

WIDER IMPLICATIONS OF THE FINDINGS:

Treatment groups had similar ovarian responses, supporting equivalence for starting doses follitropin delta 15 µg and follitropin alfa 225 IU, with low rates of early OHSS. Ovarian stimulation cycles with follitropin delta in µg can be planned and adjusted, leveraging the established IU dose equivalence to follitropin alfa.

STUDY FUNDING/COMPETING INTEREST(S):

This trial was funded by Ferring Pharmaceuticals A/S, Kastrup, Denmark. Medical writing support for manuscript development was provided by Celia J. Parkyn, PhD, and was funded by Ferring Pharmaceuticals A/S, Kastrup, Denmark. P.Z. and R.A. have none. A.B. has received grants from Gedeon Richter, IBSA, GP Pharm & Seid, Miguel Hernandez University, Centre for Technological Development and Innovation, Valencian Innovation Agency, Regional Secretary for Industry, Trade and Consumption, and the Government Ministry of Industry and Tourism; payments from University Complutense of Madrid, Ferring Pharmaceuticals, Fentypharm, Miguel Hernandez University, Gedeon Richter, & Vall d’Hebron Hospital; travel support from Ferring Pharmaceuticals, Fentypharm, Gedeon Richter, International ESHRE Congress Organising Committee, Spanish Society of Gynaecology and Obstetrics, CROG Congress Organising Committee, & Vall d’Hebron Hospital; has a patent pending for Sperm plate (U202431456); and is Chair of the Organising Committee of the Infertility and Sterility Section of the Spanish Society of Gynaecologist (non-paid role) and equipment from Obstetrics; & equipment from Cook Medical. J.S. has received consulting fees from Ferring Pharmaceuticals. E.P. has received grants from Merck, Ferring, Theramex, Gedeon Richter, IBSA, and Organon; payments from Merck, Ferring, IBSA, and Organon; travel support from Merck, IBSA, Organon, Theramex, and Ferring; and participated in a Safety Monitoring Board or Advisory Board for Merck. M.G.S. has received patient medication from Ferring; payments from Ferring, Merck for educational events; and travel support from Ferring, Merck, Theramex, and IBSA. R.L. and S.M. are employees of Ferring Pharmaceuticals. I.E.J. was an employee of Ferring Pharmaceuticals at the time of the trial conduct.

TRIAL REGISTRATION NUMBER:

clinicaltrials.gov NCT05263388; Eudract 2021-001785-38

TRIAL REGISTRATION DATE:

16 November 2021 (clinicaltrials.gov); 5 August 2021 (Eudract)

DATE OF FIRST PATIENT’S ENROLMENT:

1 August 2022

01 Sep 2025·FERTILITY AND STERILITY

Dual trigger versus GnRH-a trigger for elective fertility preservation. A randomized controlled trial

Article

Author: Rodriguez, Ignacio ; Polyzos, Nikolaos P ; García-Martinez, Sandra ; Neves, Ana Raquel ; Donno, Valeria

DESIGN:

Randomized, controlled, single-center, superiority clinical trial SUBJECTS: A total of 109 women were enrolled in this study between October 2021 and April 2023 with a 1:1 allocation. Eligible patients were ≤40 years old, with an antral follicular count <20 and anti-Mullerian hormone ≤3 ng/ml undergoing elective fertility preservation cycles.

INTERVENTION:

Controlled ovarian stimulation was performed using 225-300IU/day of follitropin alfa or beta or 15-20 μg of follitropin delta, tailored to ovarian reserve and weight. LH surge was suppressed through a progestin-primed ovarian stimulation protocol, with oral administration of micronized progesterone (200mg daily) from the beginning of ovarian stimulation until the trigger day. As soon as at least three follicles ≥ 18 mm were observed by ultrasound, patients were randomization to the intervention group (Triptorelin 0.2 mg + 250 mcg rhCG) or the control group trigger with GnRH-a alone (Triptorelin 0,2 mg).

MAIN OUTCOME MEASURES:

The primary endpoint was the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation.

RESULTS:

Overall, 109 patients were analyzed, 55 in the Dual trigger group and 54 in the control arm (GnRH-a). No statistically significant differences were found regarding the total number of oocytes nor MII oocytes retrieved between the Dual Trigger and GnRH-a groups (9.22 ± 5.11vs.9.56 ± 5.16, (EMD-0.34 [95%CI: -2.29;1.61]) and 7.31 ± 4.63vs.7.94 ± 4.39 group (EMD -0.64 [95%CI: -2.07;0.80], respectively). Likewise, no statistically significant differences were found regarding estradiol, progesterone, LH and FSH levels on the day following the trigger. Notably, neither group exhibited any case of Ovarian Hyperstimulation Syndrome (OHSS).

CONCLUSION:

In patients undergoing fertility preservation, adding hCG to GnRH-a for triggering final oocyte maturation is not superior to the administration of GnRH-a alone in terms of MII oocytes. Therefore, the selection of the trigger method should be based on both patients' and clinicians' preferences, with a focus on patients' safety and convenience.

TRIAL REGISTRATION NUMBER:

NCT04992468.

News (Medical) associated with Follitropin delta

02 Jul 2025

·pipelinereview.com

Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta

PARIS, France I July 02, 2025 I Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction . These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications. 1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI. 3 The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrieved. Currently, follitropin delta is approved for use via a dosing algorithm based on serum anti-Müllerian Hormone (AMH) and bodyweight individualised for each patient, and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile. The clinical value of this approach has been well established 4,5,6,7,8 , particularly in treatment-naïve patients where the algorithm aims to achieve 8–14 retrieved oocytes while minimising the risk of ovarian hyperstimulation syndrome (OHSS) to optimise the live birth rate in a fresh and frozen transfer cycle. 4,5,6,7,8 Key Findings: Dr Andrea Bernabeu, Medical Director at Instituto Bernabeu and principal investigator of the ADAPT-1 trial, said: “No patients we see as fertility doctors are the same and the ability to optimise therapy based on patients age, treatment goal and whether they have a high or low response to follicular stimulation are all relevant. These data provide confidence and expand our understanding for dosing in follitropin delta.” Pierre-Yves Berclaz, Chief Science and Medical Officer at Ferring Pharmaceuticals, stated: “The ADAPT-1 trial results confirm the efficacy and safety of follitropin delta across the full range of dosing strategies, making it the only recombinant FSH with robust clinical evidence supporting multiple dosing strategies. Ferring will take forward the implications of this study in future dialogue with regulatory authorities.” About GnRH protocols Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI. 7,8 About Follitropin Delta (Rekovelle ® ) Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response. 3 It is the first rFSH derived from a human cell line (PER.C6 ® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins. 3,4 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight. 3,5 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response. 5,6 The follitropin delta 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. 3 About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in areas of gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com , or connect with us on LinkedIn , Instagram , YouTube , Facebook and X . REFERENCES 1 – Arce JC, Larsson P, Garcia-Velasco JA; Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa; RBMO; 2020 2 – Yang R, Zhang Y, Liang X et al; Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization / intracytoplasmic sperm injection; Reproductive Biology and Endocrinology; 2022 3 – Clinical Trials.gov page: https://clinicaltrials.gov/study/NCT05263388 (Accessed June 2025) 4 – Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396. 5 – Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, Arce JC; ESTHER-2 Study Group. 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. 6 – 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. 7 – Qiao J, Zhang Y, Liang X, 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. 8 – Blockeel C, Griesinger G, Rago R, 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. SOURCE: Ferring Pharmaceuticals

Phase 3Clinical ResultDrug Approval

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

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	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	Belgium	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Brazil	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Canada	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Czechia	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Denmark	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	France	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Italy	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Poland	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Russia	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Spain	Ferring Pharmaceuticals A/S	01 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03740737 (RITA-1, Pubmed \| Fertil Steril)	Phase 3	Ovarian Stimulations	1,165	Follitropin delta	mngtbgnycg(vxpoeczpvh) = hbcxnfrxuo hjmtyeeblg (umplqipmvi ) View more	Positive	01 Jul 2025
				Placebo	mngtbgnycg(vxpoeczpvh) = kustbuqzqd hjmtyeeblg (umplqipmvi ) View more
NCT05263388 (ADAPT-1, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility	302	Follitropin Delta (REKOVELLE (Follitropin Delta))	bgjawevkng(ogljuplifk) = tzpykwsjpo deevkwsomv (wykfuqnvth, qgsylsjdml - jszkcuavip) View more	-	02 Apr 2025
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	bgjawevkng(ogljuplifk) = cfstyxbiov deevkwsomv (wykfuqnvth, ggkhsbrhkb - eptpiqzwbk) View more
NCT05103228 (CTgov)	Not Applicable	Infertility \| Diminished ovarian reserve \| Ovarian Diseases	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	anskdnwtvk = axizwbgfjh nvxemrumbl (urshsbkylr, tfkzftalfo - mcfewqmlvh) View more	-	13 Dec 2024
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	anskdnwtvk = whomhyzrjp nvxemrumbl (urshsbkylr, eslvliyqdq - trmtkdthrm) View more
NCT03809429 (BEYOND, CTgov)	Phase 3	Infertility, Female	437	GONAPEPTYL+FE 999049+GnRH agonist (FE 999049 + GnRH Agonist (GONAPEPTYL))	fsyybmbefk(jetvfkxozx) = kezjdlened wtwpwsvzdn (pmlhhvgfka, 5.9) View more	-	13 May 2024
				CETROTIDE+FE 999049+GnRH antagonist (FE 999049 + GnRH Antagonist (CETROTIDE))	fsyybmbefk(jetvfkxozx) = nujsfkoyjt wtwpwsvzdn (pmlhhvgfka, 5.5) View more
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) Manual	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin deltaGONAPEPTYL (GnRH agonist protocol)	ihkrygljyv(kjohmgbstr) = qyurydbdtv qudluuuwtk (rqzarqnrlu, 5.9) View more	Positive	09 May 2024
				FE 999049follitropin deltaCETROTIDE (GnRH antagonist protocol)	ihkrygljyv(kjohmgbstr) = gcarubhttc qudluuuwtk (rqzarqnrlu, 5.5) View more
NCT03738618 (RITA-2, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility, Female	588	Follitropin delta (FE 999049 (Follitropin Delta))	dkaxhsihjy = ndcxuqjbrg tmdcytuwsl (idpcnwovpa, zfxcpppdry - dtpmmyufqi) View more	-	18 Jan 2024
				Placebo (Placebo)	dkaxhsihjy = navipcsvod tmdcytuwsl (idpcnwovpa, pzqmduzzzh - qttcvciqkc) View more
NCT03740737 (RITA-1, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility \| Infertility, Male	579	Follitropin delta (FE 999049 (Follitropin Delta))	wsoqdlznne = zeprpbsymm dxqsfyteor (tbomkmoxlm, qwlhzqhuqg - thfcoucekt) View more	-	18 Jan 2024
				Placebo (Placebo)	wsoqdlznne = kmzwzemblc dxqsfyteor (tbomkmoxlm, rmpchyulwi - bysywkcrcg) View more
NCT04150861 (Pubmed)	Phase 1	-	24	Follitropin delta 12 μg	dmtibqngrc(lpicsiapfv) = lhdpkdxxza tzoyryhpnj (nifjkitrpa ) View more	-	07 Dec 2022
				Follitropin delta 18 μg	dmtibqngrc(lpicsiapfv) = qafumwusmf tzoyryhpnj (nifjkitrpa ) View more
NCT03393780 (PROFILE, Pubmed \| Front Endocrinol (Lausanne))	Not Applicable	Ovarian Stimulations	944	Follitropin delta	bmibtejpqr(akthmymuag) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) qfbkocpyuq (xubwfdklom )	Positive	01 Jan 2022
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	Phase 3	-	800	follitropin delta (Japanese women)	cdyxuqfeyx(vgubuzlkus) = wndgaedjqw ygtlytxubm (bhnvjkcduk )	-	23 Sep 2021
				follitropin delta (White women)	cdyxuqfeyx(vgubuzlkus) = kwdujwvjfy ygtlytxubm (bhnvjkcduk )

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