An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A.

Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.
Participants who are receiving treatment with damoctocog alfa pegol (n
12) or turoctocog alfa pegol (n
12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.
During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).
The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.
Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.

Start Date01 Nov 2024

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

[+1]

NCT06530030 / Not yet recruitingNot Applicable

Prospective, Observational Study of the Impact of Efanesoctocog Alfa (ALTUVIIIO®) on Goal Attainment and Physical Activity in People With Moderate or Severe Hemophilia A

This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan.
This study aims to enroll 35 patients.

Start Date15 Oct 2024

Sponsor / Collaborator

Sanofi

NCT05817812 / Active, not recruitingPhase 3

A Phase 3b Open-label Study Evaluating Physical Activity and Joint Health in Previously Treated Patients ≥12 Years With Severe Haemophilia A Treated With Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (Efanesoctocog Alfa) for 24 Months

FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study.
The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24.
Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

Start Date31 Jul 2023

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

[+1]

100 Clinical Results associated with Efanesoctocog alfa

100 Translational Medicine associated with Efanesoctocog alfa

100 Patents (Medical) associated with Efanesoctocog alfa

Literatures (Medical) associated with Efanesoctocog alfa

01 Aug 2024·PEDIATRIC BLOOD & CANCER

Practical challenges associated with efanesoctocog alfa (ALTUVIIIO) prophylaxis in a 19‐month‐old male with severe hemophilia A

Letter

Author: Español, Maria G. ; Christ, Dane C. ; Tarantino, Michael D. ; Mistretta, Jessica N. ; Roberts, Jonathan C. ; Jones, Maureen D.

23 Jul 2024·EXPERT OPINION ON PHARMACOTHERAPY

Factor VIII stimulants and other novel therapies for the treatment of von Willebrand disease: what’s new on the horizon?

Review

Author: Sidonio, Robert F. ; Regling, Katherine

INTRODUCTION:

Von Willebrand disease (VWD) is the most common inherited bleeding disorder, affecting about 0.6% to 1.3% of the population, and is characterized primarily by mucocutaneous bleeding secondary to defective platelet adhesion and aggregation. Current therapeutic options for those with severe disease are limited and require frequent intravenous infusions.

AREAS COVERED:

This review discusses the current and recently completed clinical trials involving pathways to FVIII augmentation for the treatment of VWD. Clinical trials registered on clinicaltrials.gov and published data via PubMed searches through June 2024 were included.

EXPERT OPINION:

Available treatment options to those with VWD are limited in part due to limited clinical trials, the complexity of VWD types, and the pharmacokinetics of current treatment options. The development of therapeutic options that reduce treatment burden is necessary to improve quality of life and reduce bleeding complications and in recent years there has been an increased interest from industry to apply novel therapeutics for VWD. The FVIII mimetic, emicizumab, has demonstrated early success in patients with severe VWD and is a promising treatment option for those who require prophylaxis. Furthermore, products like efanesoctocog alfa (Altuviiio®) and BT200 have achieved enhanced VWF/FVIII half-life extension could expand the current treatment landscape while concurrently minimizing treatment burden.

18 Jul 2024·NEW ENGLAND JOURNAL OF MEDICINE

Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A

Article

Author: Malec, Lynn ; Álvarez Román, Maria Teresa ; Albisetti, Manuela ; Wong, Nancy ; Staber, Janice M ; Santagostino, Elena ; Yuan, Huixing ; Simpson, Mindy ; d'Oiron, Roseline ; Zulfikar, Bulent ; Chan, Anthony K C ; Carcao, Manuel ; Yarramaneni, Abhimanyu ; Abad-Franch, Lydia ; Gunawardena, Sriya ; Peyvandi, Flora ; Königs, Christoph ; Dunn, Amy L ; Chou, Sheng-Chieh ; Fijnvandraat, Karin ; Demissie, Marek

BACKGROUND:

Once-weekly efanesoctocog alfa provides high sustained factor VIII activity with superior bleeding prevention as compared with prestudy factor VIII prophylaxis in previously treated patients 12 years of age or older with severe hemophilia A. Data on outcomes of efanesoctocog alfa treatment in children younger than 12 years of age with severe hemophilia A are limited.

METHODS:

We conducted a phase 3, open-label study involving previously treated patients younger than 12 years of age with severe hemophilia A. Patients received prophylaxis with once-weekly efanesoctocog alfa (50 IU per kilogram of body weight) for 52 weeks. The primary end point was the occurrence of factor VIII inhibitors (neutralizing antibodies against factor VIII). Secondary end points included annualized rates of treated bleeding episodes, bleeding treatment, safety, and pharmacokinetics.

RESULTS:

A total of 74 male patients were enrolled (38 with an age of <6 years and 36 with an age of 6 to <12 years). No factor VIII inhibitors developed. Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. In the 73 patients treated according to the protocol, the median and model-based mean annualized bleeding rates were 0.00 (interquartile range, 0.00 to 1.02) and 0.61 (95% confidence interval, 0.42 to 0.90), respectively. A total of 47 patients (64%) had no treated bleeding episodes, 65 (88%) had no spontaneous bleeding episodes, and 61 (82%) had no episodes of bleeding into joints. A total of 41 of 43 bleeding episodes (95%) resolved with one injection of efanesoctocog alfa. Mean factor VIII activity at steady state was more than 40 IU per deciliter for 3 days and more than 10 IU per deciliter for almost 7 days after dose administration. The geometric mean terminal half-life was 40.0 hours.

CONCLUSIONS:

In children with severe hemophilia A, once-weekly prophylaxis with efanesoctocog alfa provided high sustained factor VIII activity in the normal to near-normal range (>40 IU per deciliter) for 3 days and more than 10 IU per deciliter for almost 7 days after administration, leading to effective bleeding prevention. Efanesoctocog alfa was associated with mainly nonserious adverse events. (Funded by Sanofi and Sobi; XTEND-Kids ClinicalTrials.gov number, NCT04759131.).

News (Medical) associated with Efanesoctocog alfa

28 Oct 2024

·www.echemi.com

Merck's RSV Antibody Faces Major Challenges vs. Sanofi's Beyfortus Exhibiting 83% Efficacy in Reducing Hospitalization

While Merck & Co. 's infant respiratory syncytial virus (RSV) antibody clesrovimab is nearing approval, sanofi also won approval last year for its RSV prevention drug beyforts in partnership with astrazeneca. This news undoubtedly brings new hope to the global healthcare industry, especially in the field of RSV vaccines. "We would very much welcome having more participants on board because it increases the scale of the competition," Thomas Triomphe, Sanofi's executive vice president for vaccines, said of the upcoming RSV competition during an analyst call on Friday. He stressed that more players mean more innovation and better healthcare solutions, which is good for the industry as a whole and for patients. Triomphe noted that Merck still has more data on clesrovimab after announcing phase 2b/3 clinical results last week. In the meantime, Sanofi remains "very confident" in the Beyfortus numbers it has released so far, he said. He mentioned that the protection data provided by Beyfortus in six months is very encouraging, as the effect has not diminished. "After six months, we were still seeing 83 percent hospitalization efficacy," he said, adding that he believed "the duration of protection from Beyfortus was significantly more favorable compared to clesrovimab." This data suggests that Beyfortus has a significant advantage in preventing RSV infection. In Merck's infant RSV study, clesrovimab successfully reduced RSV-related hospitalizations and RSV-related lower respiratory tract infection hospitalizations by 84 percent and 91 percent, respectively, over five months compared to placebo. This result is impressive and shows the great potential of clesrovimab in preventing RSV infection. At the trial's primary endpoint, clesrovimab reduced the incidence of RSV-related medical lower respiratory tract infections by 60 percent compared to placebo. This data provides further evidence of the effectiveness of clesrovimab in preventing RSV infection. Sanofi Chief Financial Officer franois-xavier Roger noted in a conference call on Friday that the inherent uncertainty of cross-trial comparisons suggested that existing Beyfortus data showed a reduction of about 75 percent in the incidence of lower respiratory tract infections with clesrovimab compared to 60 percent with Clesrovimab. This data further reinforces Beyfortus' advantage in preventing RSV infection. And, whether or not Merck brings clesrovimab into the 2025-2026 RSV season as planned, "2025 will be a year of growth for Beyfortus," the CFO stressed. He is confident that Beyfortus' sales will grow significantly as it gradually gains market share. Since it was approved last July, Beyfortus has gradually built up its sales profile. In the third quarter of 2024, sales of this preventive antibody reached 645 million euros ($699), an increase of 382% compared to the same period in 2023. Overall, sales of the drug have reached 845 million euros since the beginning of the year, which is close to the best-selling threshold. Sanofi said at the time that Beyfortus quickly fell into a supply crunch shortly after going public last year due to "higher than expected demand." To counter this, Sanofi and its partner Astrazeneca have moved quickly to ensure there is no repeat of the supply crunch in 2024. Recently they added a new filling line and shipped antibody doses ahead of the 2024 RSV season. "There are 20 markets and we don't see any capacity constraints," Triumph said on Sanofi's conference call. "We will increase supply next year and the year after to make sure there are no supply constraints." This initiative demonstrates Sanofi's confidence in the future of Beyfortus and its commitment to meeting the needs of the global market. The comments by Sanofi executives came as the French pharmaceutical company reported a 15.7 per cent rise in third-quarter sales. This growth was mainly driven by the excellent performance of its immunology product Dupixent, which brought in sales of nearly 3.5 billion euros (about $3.8 billion), an increase of about 24 percent over the third quarter of 2023. Sanofi confirmed DuPont's full-year sales target of about 13 billion euros. Elsewhere, newly launched drugs rose 67.1 percent to 727 million euros ($787), led by hemophilia drug Altuviiio, Pompeii disease treatment Nexviazyme and Rezurock for graft-versus-host disease. The strong performance of these new drugs further strengthens Sanofi's position in the field of innovative medicines. Meanwhile, Sanofi's consumer health division, Opella, saw revenue rise 7.9 percent. This growth shows that Sanofi is also making significant progress in consumer health. Earlier this week, Sanofi confirmed it had entered exclusive talks with U.S. private equity firm Clayton, Dubilier & Rice to sell a controlling 50 percent stake in its consumer healthcare business, which is valued at around 16 billion euros. This move will further strengthen Sanofi's financial strength and provide additional financial support for its future expansion.

Drug ApprovalClinical ResultVaccine

24 Oct 2024

·www.prnewswire.com

Sobi Q3 2024 report: Strong growth and significant pipeline momentum

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024 Third Quarter 2024 Total revenue increased 33 per cent, 39 per cent at constant exchange rates, (CER)1, to SEK 6,894 M (5,168) Haematology revenue increased 18 per cent at CER to SEK 4,000 M (3,484), mainly driven by strong sales of Doptelet® of SEK 1,039 M (650), sales of Aspaveli®/Empaveli® of SEK 270 M (169) and launch sales of Altuvoct® of SEK 129 M (—) Immunology revenue increased 96 per cent at CER to SEK 2,583 M (1,400), driven by strong Beyfortus® royalty of SEK 1,478 M (263) and sales of Kineret® of SEK 699 M (600) Revenue from medicines in the strategic portfolio* grew by 113 per cent at CER to SEK 3,830 M (1,924) The adjusted EBITA margin1,2 was 43 per cent (30), excluding items affecting comparability (IAC)2. EBITA was SEK 2,923 M (1,443), corresponding to a margin of 42 per cent (28). EBIT was SEK 2,038 M (547) Earnings per share (EPS) before dilution was SEK 4.27 (0.30). Adjusted EPS before dilution1 was SEK 4.36 (0.54). Cash flow from operating activities was SEK 1,201 M (1,058) In August, Sobi and Apellis Pharmaceuticals announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN Outlook 2024 - Updated Revenue is anticipated to grow by a mid-teens percentage at CER (previously low double-digit) The adjusted EBITA margin is anticipated to be in the mid-30s percentage of revenue (unchanged) Click here for the Financial Summary. Alternative Performance Measures (APMs). Items affecting comparability (IAC). * The strategic portfolio includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant®, Vonjo® and Zynlonta®, and royalty on Sanofi's sales of Altuviiio® and Beyfortus. Investors, analysts, and the media are invited to a conference call on the same day at 14:00 CEST, 13:00 BST, and 08:00 EDT. The call will include a presentation of the results and a Q&A session. The presentation can be followed live here or afterwards on sobi.com. The slides will be made available on sobi.com before the conference call. To participate in the conference call, please use the following dial-in details: Sweden: +46 8 5051 0031 United Kingdom: +44 207 107 06 13 United States: +1 631 570 56 13 For other countries, please find the details here. Sobi Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CEST on 24 October 2024. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementClinical ResultPhase 3Biosimilar

14 Oct 2024

·www.biopharmadive.com

Pfizer drug for hemophilia approved by FDA

Dive Brief:The Food and Drug Administration on Friday approved a new kind of medicine for hemophilia, clearing Pfizers Hympavzi for people with either the A or B forms of the inherited bleeding condition.Adults and children 12 years of age or older who havent developed proteins, or inhibitors, that prevent clotting drugs from working well are eligible to receive Hympavzi, the FDA said. The drug is taken once per week via an under-the-skin injection.Typically, medicines for hemophilia replace the blood clotting factor that people with the disease lack. By contrast, Hympavzi works by reducing activity of an anticoagulatory protein called tissue factor pathway inhibitor, or TFPI. This increases enzymes that help blood clump together,which in turn can prevent bleeding from occurring.Dive Insight:Approval of Hympavzi expands Pfizers portfolio of hemophilia medicines months after the company secured U.S. clearance of a gene therapy for the B form of the condition. Another of the companys gene therapies, for the A form, recently met the goals of a late-stage study, too.We look forward to launching this latest medical breakthrough and to now offer three distinct classes of hemophilia medicines an anti-TFPI, gene therapy, and recombinant factor treatments that can meet the unique treatment needs of a wide range of patients, said Aamir Malik, Pfizers U.S. commercial chief, in a statement.The drug is part of a new generation of treatments that are reaching market, substantially expanding the options patients with the condition have. Roches Hemlibra has become a new preventive standard for people with hemophilia A, while Sanofi recently secured approval of a long-acting factor replacement drug called Altuviiio.The new options have complicated the case for gene therapy, which promises a yearslong fix for the condition with a single infusion. Uptake of treatments from CSL Behring, BioMarin Pharmaceutical and, most recently, Pfizer, has been slow.Hympavzi offers more flexibility, both in its weekly dosing and in its utility for both hemophilia A and B. In testing, preventive treatment with Pfizers drug proved superior to on-demand use of factor replacement, substantially lowering annualized bleeding rates. Bleeding rates with Hympavzi were lower compared to preventive factor treatment as well.Treatment with Hympavzi was commonly associated with injection site reactions, headache and itching. The FDAs label for the drug also warns of circulating blood clots, hypersensitivity and embryofetal toxicity.Regulators in Europe recommended clearance for Hympavzi last month, sending it to the European Commission for marketing authorization.The regulatory advances are good news for Pfizer, which has struggled through a series of research setbacks and doubts about its growth that recently culminated in a public challenge from activist investor Starboard Value. '

Drug ApprovalGene Therapy

100 Deals associated with Efanesoctocog alfa

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Indication	Country/Location	Organization	Date
Hemophilia A	US	Bioverativ Therapeutics, Inc.	22 Feb 2023
Hemophilia A	US	Bioverativ, Inc.	22 Feb 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Von Willebrand Disease, Type 2	Phase 1	US	Bioverativ, Inc.	03 May 2021
Von Willebrand Disease, Type 2	Phase 1	FR	Bioverativ, Inc.	03 May 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04759131 (XTEND-Kids, PRNewswire) Manual	Phase 3	Hemophilia A	73	ALTUVOCT	fkqzczimty(ebteghtwff) = tjauiigpsg hgaoaqiziu (blvrundrvv, 0.42–0.90) View more	Positive	18 Jul 2024
NCT04759131 (XTEND-Kids, Pubmed)	Phase 3	Hemophilia A	74	Efanesoctocog alfa	kzemqtmhit(gakhkcuics) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. hmejdxzjru (xfxdovkona )	Positive	18 Jul 2024
NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) Manual	Phase 1	Hemophilia A FVIII	13	Octocog alfa	dcflaagoxh(xchfqcpjbg) = ojfjcgeiai ygpxhrmyte (mlnakywwkz ) View more	Positive	14 May 2024
	Phase 1	Hemophilia A FVIII	13	Rurioctocog alfa pegol	dcflaagoxh(xchfqcpjbg) = ogmgpmyejt ygpxhrmyte (mlnakywwkz ) View more	Positive	14 May 2024
NCT04759131 (XTEND-Kids, CTgov)	Phase 3	Hemophilia A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged <6 Years)	sgwyqycsav(tbuzbqdfsg) = yyhfcvsbwd nkvqzbiqsr (nzgrgzstmn, ifzmokhudn - awxbbzfoqt) View more	-	13 Feb 2024
NCT04759131 (XTEND-Kids, CTgov)	Phase 3	Hemophilia A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged 6 to <12 Years)	sgwyqycsav(tbuzbqdfsg) = uwoxehfarz nkvqzbiqsr (nzgrgzstmn, pudmmgctgs - edogijpagn) View more	-	13 Feb 2024
XTEND-1 (ISTH2023)	Phase 3	Hemophilia A	78	Standard-of-care FVIII prophylaxis	mvgnvnophf(gpjhozjgjn) = adotakdecd astilgfkfq (brommzlgzj )	-	24 Jun 2023
XTEND-1 (ISTH2023)	Phase 3	Hemophilia A	78	Efanesoctocog alfa 50 IU/kg prophylaxis	mvgnvnophf(gpjhozjgjn) = bkxbzkfpgb astilgfkfq (brommzlgzj )	-	24 Jun 2023
NCT04161495 (XTEND-1, ASH2022) Manual	Phase 3	Pain \| Hemophilia A	159	Efanesoctocog alfa (Arm A)	ndobqtzkbe(hldwbhddqt) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 chaaxyfatg (ffngndbhvy )	Positive	15 Nov 2022
NCT04161495 (XTEND-1, ASH2022) Manual	Phase 3	Pain \| Hemophilia A	159	Efanesoctocog alfa (Arm B)		Positive	15 Nov 2022
NCT04161495 (XTEND-1, ASH2022) Manual	Phase 3	Hemophilia A	159	Efanesoctocog alfa	tixeyfctwn(sudsqzladd) = xeuauavahi pqwbvoijji (hbwiurnylv ) View more	Positive	15 Nov 2022
NCT04161495 (XTEND-1, Corporate Publications) Manual	Phase 3	Hemorrhage	150	Efanesoctocog alfa	tzfosrqrcc(usgeuuhmkj) = ntyhowdegd valhugxufl (jazwdwawfb )	Positive	11 Jul 2022
XTEND-1 (ISTH2022)	Phase 3	Hemophilia A	217	Efanesoctocog Alfa (BIVV001)	lpmblbxird(anrnnqpdqp) = svudxlolmz vihvngqexn (uxugvlmbxf )	-	09 Jul 2022
NCT04161495 (XTEND-1, Corporate Publications) Manual	Phase 3	Hemophilia A	-	efanesoctocog alfa	hhphbifmpk(daoewdaasf) = ohjetdwpxe cdxhqyvsfj (pfhmkacogr ) View more	Positive	09 Mar 2022

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