（1）评价该吸入制剂在健康受试者中单次给药的耐受性和药代动力学特征；（2）以药代动力学参数作为主要终点评价指标，比较该吸入制剂与注射制剂在健康受试者体内的药代动力学行为，计算该吸入制剂的绝对生物利用度；（3）比较该吸入制剂与注射制剂在健康受试者鼻咽部及肺泡中的暴露量；评价该吸入制剂在健康受试者中多次给药的耐受性及药代动力学特征。

[Translation]

(1) Evaluate the tolerability and pharmacokinetic characteristics of the inhalation preparation after a single dose in healthy subjects; (2) Compare the pharmacokinetic behavior of the inhalation preparation and the injection preparation in healthy subjects using pharmacokinetic parameters as the primary endpoint evaluation indicators, and calculate the absolute bioavailability of the inhalation preparation; (3) Compare the exposure of the inhalation preparation and the injection preparation in the nasopharynx and alveoli of healthy subjects; Evaluate the tolerability and pharmacokinetic characteristics of the inhalation preparation after multiple doses in healthy subjects.

Start Date24 Jun 2024

Sponsor / Collaborator

Langtian Pharmaceutical Technology (Wuhan) Co., Ltd.

[+1]

CTR20233494 / Active, not recruitingPhase 2

初步评价帕拉米韦吸入溶液治疗成人无并发症的单纯性流感的有效性及安全性的多中心、随机、双盲、安慰剂对照的Ⅱ期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to preliminarily evaluate the efficacy and safety of peramivir inhalation solution in the treatment of uncomplicated influenza in adults

主要研究目的：考察不同剂量、不同次数帕拉米韦吸入溶液对比安慰剂治疗成人无并发症的单纯性流感患者的安全性及有效性，为疗效确证阶段给药方案的确定提供依据。次要研究目的：基于群体药代动力学（PopPK）分析方法，评价帕拉米韦吸入溶液在成人无并发症的单纯性流感患者中的 PK 特征及暴露-效应关系。

[Translation]

The main purpose of the study is to investigate the safety and efficacy of different doses and different times of peramivir inhalation solution compared with placebo in the treatment of uncomplicated uncomplicated influenza in adults, and to provide a basis for determining the dosing regimen in the efficacy confirmation phase. The secondary purpose of the study is to evaluate the PK characteristics and exposure-effect relationship of peramivir inhalation solution in uncomplicated uncomplicated influenza in adults based on the population pharmacokinetic (PopPK) analysis method.

Start Date13 Nov 2023

Sponsor / Collaborator

Guangzhou Nanxin Pharma Co Ltd

ChiCTR2300070071 / SuspendedPhase 1IIT

Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of single and multiple doses of peramivir inhalation solution in healthy Chinese adult subjects

Start Date17 Mar 2023

Sponsor / Collaborator-

100 Clinical Results associated with Peramivir

100 Translational Medicine associated with Peramivir

100 Patents (Medical) associated with Peramivir

470

Literatures (Medical) associated with Peramivir

01 Nov 2024·Internal medicine (Tokyo, Japan)

Efficacy of Pharmacotherapy for Seasonal Influenza in Young and Middle-aged Adults: A Systematic Review and Network Meta-analysis

Review

Author: Miyata, Jun ; Hanaki, Nao ; Noguchi, Midori ; Moromizato, Takuhiro ; Iso, Hiroyasu ; Ishimura, Keiko ; Sakaniwa, Ryoto

Objective Seasonal influenza affects healthcare demand. However, the efficacy of anti-influenza drugs, particularly among young patients at a low risk of complications, has rarely been evaluated. Therefore, we evaluated the efficacy of anti-influenza drugs against seasonal influenza in healthy young and middle-aged adults. Methods A systematic review and network meta-analysis were conducted. The Cochrane Central Register of Controlled Trials and Medical Literature Analysis and Retrieval System Online were searched for original articles reporting double-blind, randomized controlled trials published up to the end of July 2023. Clinical trials that tested the efficacy of anti-influenza drugs in young and middle-aged patients with seasonal influenza were also included. The primary outcome was time to fever alleviation. The efficacy and adverse effects of these treatments were estimated using a Bayesian hierarchical random-effects model and a Markov chain Monte Carlo simulation. Results In total, 24 articles with 34 treatments and 8,949 individuals were included. Oseltamivir (300 mg/day for 5 days) showed the largest reduction in time to fever alleviation by -19.1 [95% confidence interval (CI): -29.4, -10.7] h compared with a placebo. Baloxavir marboxil (40 mg/day) reduced the time to symptom alleviation by -28.2 (95% CI: -42.7, -13.7) h, and peramivir (300 mg/day) administered by intravenous infusion for 1 day reduced the time to resumption of usual activities by -43.5 (95% CI: -72.8, -14.2) h. Conclusion Several pharmaceutical treatments were able to reduce the recovery time for fever and symptom alleviation and resumption of usual activities in young and middle-aged adults with seasonal influenza without increasing the risk of complications.

01 Nov 2024·SCIENCE OF THE TOTAL ENVIRONMENT

Occurrence and environmental fate of anti-influenza drugs in a subcatchment of the Yodo River Basin, Japan

Article

Author: Azuma, Takashi ; Usui, Masaru ; Hasei, Tomohiro ; Hayashi, Tetsuya

Understanding the current situation and risk of environmental contamination by anti-influenza drugs in aquatic environments is key to prevent the unexpected emergence and spread of drug-resistant viruses. However, few reports have been focused on newer drugs that have recently been introduced in clinical settings. In this study, the behaviour of the prodrug baloxavir marboxil (BALM)-the active ingredient of Xofluza, an increasingly popular anti-influenza drug-and its pharmacologically active metabolite baloxavir (BAL) in the aquatic environment was evaluated. Additionally, their presence in urban rivers and a wastewater treatment plant (WWTP) in the Yodo River basin was investigated and compared with those of the major anti-influenza drugs used to date (favipiravir (FAV), peramivir (PER), laninamivir (LAN), and its active metabolite, laninamivir octanoate (LANO), oseltamivir (OSE), and its active metabolite, oseltamivir carboxylate (OSEC), and zanamivir (ZAN)) to comprehensively assess their environmental fate in the aquatic environment. The results clearly showed that BALM, FAV, and BAL were rapidly degraded through photolysis (2-h, 0.6-h, and 0.4-h half-lives, respectively), followed by LAN, which was gradually biodegraded (7-h half-life). In addition, BALM and BAL decreased by up to 47 % after 4 days and 34 % after 2 days of biodegradation in river water. However, the remaining conventional drugs, except for LANO (<1 % after 10 days), were persistent, being transported from the upstream to downstream sites. The LogK_d values for the rates of sorption of BALM (0.5-1.6) and BAL (1.8-3.1) on river sediment were higher than those of conventional drugs (-0.5 to 1.7). Notably, all anti-influenza drugs were effectively removed by ozonation (>90-99.9 % removal) after biological treatment at a WWTP. Thus, these findings suggest the importance of introducing ozonation to reduce pollution loads in rivers and the environmental risks associated with drug-resistant viruses in aquatic environments, thereby promoting safe river environments.

02 Jul 2024·Biotechnology & genetic engineering reviews

Fighting the flu: a brief review on anti-influenza agents

Review

Author: Chakraborty, Sambuddha ; Chauhan, Ashwini

The influenza virus causes one of the most prevalent and lethal infectious viral diseases of the respiratory system; the disease progression varies from acute self-limiting mild fever to disease chronicity and death. Although both the preventive and treatment measures have been vital in protecting humans against seasonal epidemics or sporadic pandemics, there are several challenges to curb the influenza virus such as limited or poor cross-protection against circulating virus strains, moderate protection in immune-compromised patients, and rapid emergence of resistance. Currently, there are four US-FDA-approved anti-influenza drugs to treat flu infection, viz. Rapivab, Relenza, Tamiflu, and Xofluza. These drugs are classified based on their mode of action against the viral replication cycle with the first three being Neuraminidase inhibitors, and the fourth one targeting the viral polymerase. The emergence of the drug-resistant strains of influenza, however, underscores the need for continuous innovation towards development and discovery of new anti-influenza agents with enhanced antiviral effects, greater safety, and improved tolerability. Here in this review, we highlighted commercially available antiviral agents besides those that are at different stages of development including under clinical trials, with a brief account of their antiviral mechanisms.

126

News (Medical) associated with Peramivir

03 Oct 2024

·endpts.com

Pfizer lays off staff in Ireland; Baxter closes NC facility due to hurricane damage

Welcome to Endpoints News ’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Pfizer is laying off employees across its manufacturing facilities in Ireland, including at Grange Castle, Ringaskiddy and Newbridge. The workforce cuts will start in the last quarter of this year and will continue into next year, the company confirmed to Endpoints News in an email. No further details were given. Baxter Pharmaceuticals has closed it North Cove facility in Marion, NC, due to Hurricane Helene causing “excessive” rain and flooding damage. The company is working to get the site back up and running, and its utilizing the rest of its manufacturing network to try and mitigate any potential supply issues. While the full impact of the site closure has yet to be seen, this will have a “negative” impact on the company’s annual revenue, Baxter said in a release on Sunday. Recipharm announced on Thursday it’s expanding its clinical and commercial pharmaceutical development and manufacturing offerings. The CDMO is expanding its small molecule site in Bengaluru, India, by adding a lab for developing sterile products. The company has also added a manufacturing line at its Wasserburg, Germany, site and has expanded its site in Kaysersberg, France. No financial details were disclosed. Recipharm also partnered with US-based CDMO Exela Pharma Sciences this week, to expand sterile manufacturing offerings in the US, the company said on Tuesday. The new partnership will give Recipharm access to Exela’s factory in Lenoir, NC, which houses abilities in manufacturing sterile injectables in vials and pre-filled syringes. India-based CDMO Piramal Pharma Solutions is investing $80 million to expand its sterile injectable facility in Lexington, KY, the company said on Monday. The expansion will add 24,000 square feet of capacity, including a new laboratory and manufacturing space. The expansion is anticipated to be finished in the first quarter of 2027. Bill and Melinda Gates Foundation-backed TerraPower Isotopes is now commercially producing the radioisotope Actinium-225 , the company announced on Tuesday. California-based SK pharmteco is injecting $260 million to build a new small molecule and peptide manufacturing facility in Sejong, South Korea, the company said on Sunday. The 135,800 square-foot facility will house R&D facilities as well as clinical and commercial manufacturing capabilities. Operations are anticipated to start in late 2026. Radioisotope producer Nusano has raised over $115 million in a Series C funding round, the company said on Tuesday. The raise will be used to help the company launch new products, including non-carrier-added lutetium-177 and actinium-225. BioCryst Pharmaceuticals has been awarded a $69 million contract from the US Department of Health and Human Services, according to a Monday announcement. Under the new contract, BioCryst will supply up to 95,625 doses of its flu vaccine, Rapivab, to the US government’s national stockpile over five years. Cell therapy CDMO Excellos has been chosen by Galapagos to make its CAR-T cell therapy asset, dubbed GLPG5101, for a Phase 1/2 clinical trial in patients with relapsed or refractory non-Hodgkin lymphoma. Excellos will make the candidate at its site in San Diego, CA, according to the Tuesday press release. Ferring Pharmaceuticals has opened a new 25,000 square-meter manufacturing site in Kuopio, Finland, which will make drug substances for its gene therapy Adstiladrin, a treatment for patients with non-muscle invasive bladder cancer, the company said on Thursday. Ginkgo Bioworks and Virica Biotech are partnering to reduce the cost of manufacturing gene therapies, the companies said on Thursday. Both companies are providing and integrating their gene therapy manufacturing platforms to offer a combined service to customers.

VaccineImmunotherapyCell Therapy

01 Oct 2024

·www.pharmaceutical-technology.com

BioCryst secures $69m contract from US to supply RAPIVAB for influenza

The injection has been approved in the US to treat simple flu cases in patients as young as six months. Credit: pedro7merino via Shutterstock. BioCryst Pharmaceuticals has received a contract valued at up to $69m from the US Department of Health and Human Services (HHS) for the procurement of RAPIVAB to treat influenza. This contract is intended to bolster the US Strategic National Stockpile (SNS) with up to 95,625 doses over a five-year period. The HHS Office of the Administration for Strategic Preparedness and Response (ASPR) structured the contract with a one-year base ordering period and four optional one-year periods. ASPR has already committed $13.9m for the initial order, with BioCryst planning to deliver 19,125 doses by 29 September 2025. RAPIVAB, used in the H1N1 influenza pandemic under an emergency use authorisation in 2009, was previously part of a $34.7m contract for the SNS, completed by BioCryst in 2022. See Also: Cyclin Dependent Kinase 4 drugs in development, 2024 Modalis wins FDA rare paediatric designation for CMD CRISPR therapy It is approved in the US for acute uncomplicated influenza treatment in patients from six months of age and above who have been symptomatic for no more than two days. BioCryst chief research and development officer Dr Helen Thackray said: “Since the 2009 H1N1 pandemic, RAPIVAB has been an important component of the US government’s influenza preparedness efforts. “As we continue to see emerging changes to circulating influenza viruses, we are pleased to fulfil this order to ensure RAPIVAB remains readily available as a therapeutic option in the event of a potential serious influenza outbreak.” Administered intravenously, RAPIVAB’s efficacy is supported by clinical trials with the predominant infections being influenza A virus, and a smaller number of cases with influenza B virus. The recommended doses are 600mg for adults and adolescents, and 12mg per kilogram for six months to 12-year-old children. BioCryst gained marketing authorisation from Chile’s Public Health Institute in May 2023, for ORLADEYO, an oral treatment for hereditary angioedema attacks in patients aged 12 years and above.

Drug ApprovalLicense out/in

30 Sep 2024

·www.globenewswire.com

U.S. Government Awards BioCryst $69 Million RAPIVAB® (peramivir injection) Contract for Strategic National Stockpile

RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Department of Health and Human Services (HHS) has awarded BioCryst up to a $69 million contract for the procurement of up to 95,625 doses over a five-year period of RAPIVAB® (peramivir injection) for the treatment of influenza. The contract, awarded by the HHS Office of the Administration for Strategic Preparedness and Response (ASPR), will supply the Center for the Strategic National Stockpile (SNS), the nation’s largest supply of life-saving pharmaceuticals and medical supplies for use in a public health emergency. The contract is structured with a 12-month base ordering period and four optional 12-month ordering periods, which the government can exercise on an annual basis. ASPR has executed the first ordering period for $13.9 million and BioCryst plans to supply 19,125 doses to fulfill this option between now and September 29, 2025. “Since the 2009 H1N1 pandemic, RAPIVAB has been an important component of the U.S. government’s influenza preparedness efforts. As we continue to see emerging changes to circulating influenza viruses, we are pleased to fulfill this order to ensure RAPIVAB remains readily available as a therapeutic option in the event of a potential serious influenza outbreak,” said Dr. Helen Thackray, chief research and development officer of BioCryst. RAPIVAB was originally stockpiled by the U.S. government under an emergency use authorization in 2009 during the H1N1 influenza pandemic. In 2018, the Centers for Disease Control and Prevention awarded the company a $34.7 million contract for the procurement of up to 50,000 doses of RAPIVAB over a five-year period for the SNS, which was completed by BioCryst in 2022. About RAPIVAB® (peramivir injection)RAPIVAB® (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. It is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg for adults and adolescents and 12 mg/kg for pediatric patients ages six months to 12 years. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit www.rapivab.com to learn more. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit www.biocryst.com or follow us on LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for RAPIVAB. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the HHS may purchase smaller quantities of RAPIVAB than currently anticipated, or none at all; BioCryst relies on third-party manufacturers to manufacture RAPIVAB in a timely manner and in accordance with applicable governmental regulations, and any failure of such third-party manufacturers to perform their obligations could impact BioCryst’s ability to supply RAPIVAB pursuant to the HHS procurement contract; and government contracts contain certain terms and conditions, including termination provisions, that subject BioCryst to additional risks. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements. BCRXW Contact:John Bluth+1 919 859 7910jbluth@biocryst.com

Drug Approval

100 Deals associated with Peramivir

External Link

KEGG	Wiki	ATC	Drug Bank
D03829	Peramivir	J05AH03	DB06614

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	KR	Green Cross Holdings Corp.	13 Aug 2010
Influenza A virus infection	JP	Shionogi & Co., Ltd.	13 Jan 2010
Influenza B virus infection	JP	Shionogi & Co., Ltd.	13 Jan 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Phase 3	CN	BioCryst Pharmaceuticals, Inc.	01 Feb 2011
Fever	Phase 3	US	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	AR	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	BE	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	BA	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	BR	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	BG	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	CA	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	CL	BioCryst Pharmaceuticals, Inc.	01 Nov 2009
Fever	Phase 3	CZ	BioCryst Pharmaceuticals, Inc.	01 Nov 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02369159 (CTgov)	Phase 3	Influenza, Human	137	Oseltamivir	jtazbdwxud(aklvtlqvil) = cjhkplidtu tyssfcxdwp (ldbzfmgmhj, sdahhrtyhw - hfsqxazfma) View more	-	23 Mar 2021
NCT02635724 (CTgov)	Phase 3	Influenza, Human	74	peramivir (At Risk (<65 Years))	idvvbcdwiz(mvvxkqawbj) = odobivntos rgamsolswp (igluigecqk, kryokczwif - ueukfrmqer) View more	-	23 Mar 2021
				peramivir (Elderly (65-75 Years))	idvvbcdwiz(mvvxkqawbj) = vhrnazgqji rgamsolswp (igluigecqk, isjwhqwryv - fudabnipnx) View more
NCT00610935 (CTgov)	Phase 3	Influenza, Human	82	Placebo (Placebo)	cqujouxbjg(eqqkmbsoua) = vbgtmummgp wzwgsovffg (zfxwlwxatk, pkhrdsjnrr - evgqzcnait) View more	-	17 Mar 2021
				Peramivir (Peramivir)	cqujouxbjg(eqqkmbsoua) = cxlgoahghh wzwgsovffg (zfxwlwxatk, drsoucrehm - pdywugfqkl) View more
NCT02609399 (CTgov)	Phase 4	Influenza, Human	180	Oseltamivir (Oseltamivir)	pupsijbogm(ozmzeredlp) = tmyfsrrxgx rpnjczdkou (ephcliqcdo, dsuszuycdl - aolhgnmrll) View more	-	20 Jun 2018
				Peramivir (Peramivir)	pupsijbogm(ozmzeredlp) = nlsdzmphtt rpnjczdkou (ephcliqcdo, fggwxomzca - gxlbyflpji) View more
NCT00705406 (CTgov)	Phase 2	Influenza, Human	405	Placebo (Placebo)	eppolsueci(xfhxxvflos) = rmoyofoqbt fsarsaiqmi (upanywgglv, gzayvxuzjt - pqmfoiodav) View more	-	16 Feb 2015
				Peramivir (Peramivir 600 mg)	eppolsueci(xfhxxvflos) = qxzztwxubm fsarsaiqmi (upanywgglv, afrjfphrej - vsslhjetda) View more
NCT00453999 (CTgov)	Phase 2	Influenza, Human	137	Peramivir (Peramivir 200 mg)	awoowjglkv(uwfespbspn) = unqchocquz anxhskdzic (fytvllaeou, xqnarakcka - fmbwyplktz) View more	-	12 Feb 2015
				Peramivir (Peramivir 400 mg)	awoowjglkv(uwfespbspn) = fdvqyqlqmw anxhskdzic (fytvllaeou, xgjjcaygqa - ctlipzquks) View more
NCT00958776 (CTgov)	Phase 3	Cough \| Fever \| Pharyngitis ... View more	405	Placebo+SOC (Placebo+SOC)	ccvfouzyek(ctkhiffhib) = tijhiuxbrr kcnalrivzi (edrbydbwtv, qoqdpbgmei - jzurgmnhkp) View more	-	12 Feb 2015
				Peramivir (Peramivir+SOC)	ccvfouzyek(ctkhiffhib) = snvnltvxjl kcnalrivzi (edrbydbwtv, hpzxvuyruv - fluobornnu) View more
NCT00419263 (CTgov)	Phase 2	Influenza, Human	344	Placebo (Placebo)	wxzdvvvjua(cswxgtazbb) = xfarsricxz jofamkatst (mpdewxoeou, xfqyqurued - xcmjzffbso) View more	-	12 Feb 2015
				Peramivir 150 mg (Peramivir 150 mg)	wxzdvvvjua(cswxgtazbb) = dclbvshars jofamkatst (mpdewxoeou, vcarwaduoq - ovqjtipior) View more
NCT00957996 (CTgov)	Phase 3	Cough \| Fatigue \| Myalgia ... View more	234	Peramivir (Peramivir 300 mg)	laehlxucam(usuymghwmk) = gotjuowqtz uvhdmlpdza (uywqsmzoyg, hhookyxjus - sszpnaxhwe) View more	-	12 Feb 2015
				Peramivir (Peramivir 600 mg)	laehlxucam(usuymghwmk) = tbrsqgykhh uvhdmlpdza (uywqsmzoyg, jrapmmziwh - zxwkeyyvxa) View more
NCT00958776 (Pubmed \| Clin Infect Dis)	Phase 3	Influenza, Human	405	Intravenous Peramivir	vjyhjuzvmt(mtludempbd) = gnsxyxwbzp csdeezyskv (bctyeftmkf, 34.0 - 57.9)	Negative	15 Dec 2014
				Placebo	vjyhjuzvmt(mtludempbd) = bhbzlsiyqc csdeezyskv (bctyeftmkf, 40.0 - 61.9)

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