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SC-001 (SP009 / SC001)

✓ Approved

Declion Pharmaceuticals · · 多肽类

什么是 SC-001？

SC-001 是一种多肽类，由Declion Pharmaceuticals研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intradermal Injection。

药物档案

商品名SP009, SC001
公司Declion Pharmaceuticals
药物类别多肽类
给药途径Injectable (Others), Intradermal Injection
状态Approved
来源： ClinicalTrials.gov, Declion Pharmaceuticals

作用机制

分子靶点

SC-001 作用于 1 个分子靶点：

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需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

SC-001 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Surgical and medical proceduresBotulinum toxin injection✓ Approved

相关研究文献

PubMedTherapeutic advances in neurological disorders2026-09-10

Use of subcutaneous natalizumab in routine care - Final results of a non-interventional, observational study (SISTER) in Germany and Austria.

Gold Ralf R, Schmidt Stephan S, Deisenhammer Florian F, Motte Jeremias J et al.

Natalizumab is a disease-modifying therapy for patients with relapsing-remitting multiple sclerosis (RRMS). In addition to its original intravenous (IV) formulation, a subcutaneous (SC) route of administration (RoA) was approved in 2021. Subsequently, the observational SISTER study was initiated in Germany and Austria to generate real-world data on the utilization, patient preferences, safety, and effectiveness of natalizumab in everyday clinical practice. The primary objective was to compare patients' preference of RoA and satisfaction with SC vs. IV natalizumab at baseline and up to 12 months of treatment. Secondary objectives included drug utilization, effectiveness outcomes, safety, and treatment satisfaction with natalizumab. SISTER was a prospective, multicenter, observational study on RRMS patients who were allocated to 3 parallel treatment cohorts: Patients switching from IV to SC natalizumab (SC switcher) and patients starting natalizumab on either the SC or IV route (starter SC/IV). The final study analyses were based on 310 patients (220 switchers, 44 SC starters, 46 IV starters) with an observation period of 10.8±3.1 months. Patient preference for the initial RoA at baseline was 95.1% among SC starters and 77.5% among IV starters (p=0.045). More IV starters than SC starters or SC switchers at baseline and Month 6 wished to change the initial RoA. Disease activity remained low in all cohorts, and the AE pattern was consistent with the known safety profile of natalizumab. The procedure duration was distinctly shorter on SC treatment than on IV treatment. The final SISTER results suggest a patient preference for the SC vs. IV route and support the outcomes of the NOVA Part 2 trial, in which the preference of the SC route over IV was demonstrated in a cross-over design. The SC route allowed relevant time savings, and its good safety and tolerability argues for possible self-administration of SC natalizumab.

PMID 42719433
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PubMedCase reports in psychiatry2026-09-10

Clinical Consequences of Inadvertent Intramuscular Administration of Subcutaneous Risperidone Formulation.

Ashley Emma E, Aalomerovic Arnela A, Blackmer Kyle K, El-Mallakh Rif S RS

Long-acting injectable (LAI) antipsychotics have been predominately administered intramuscularly (IM). Recently, subcutaneous (SC) formulations have been developed. Information regarding what occurs when the drug is not administered properly is lacking. A 23-year-old woman with bipolar disorder, currently manic with psychosis, was responding well to a combination of lithium and risperidone. She accepted a LAI of SC risperidone, but the drug was administered IM by error. The improvement she had already displayed was partially lost, and oral risperidone had to be reinitiated. She complained of mild pain at the injection site, but no other adverse consequences were noted. When a SC formulation is administered IM, it results in mild muscle pain, and unpredictable release of risperidone, but no other notable clinical problems.

PMID 42719610
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PubMedExperimental and therapeutic medicine2026-09-10

Retrospective study of infusion-related reactions in subcutaneous daratumumab administration in Japan.

Ino Yoko Y, Tanaka Kazuhide K, Ito Fuka F, Yamagishi Nao N et al.

The subcutaneous formulation of daratumumab (DARA-SC), an improved version of the intravenous formulation, has reduced administration time compared to the latter. However, real-world data regarding its infusion-related reactions (IRRs) remain limited. The present study evaluated the incidence rate, timing and risk factors for IRRs associated with the first dose of DARA-SC. This retrospective analysis included 65 patients who received their first DARA-SC dose at Gifu Municipal Hospital, Japan between May 2021 and June 2024. IRRs occurred in 10 patients (15.4%), and all cases were mild, categorized as grade 1 or 2. The median time to IRR onset was 10 h (range, 0.5-46 h), and delayed-onset IRRs (occurring after 24 h) accounted for 30% of cases. Univariate analysis identified a history of allergies as a potential factor associated with IRR occurrence (P=0.04). Older patients (≥70 years) tended to experience delayed-onset IRRs. Although these findings should be interpreted cautiously because of the limited cohort size, careful monitoring during initial DARA-SC administration might be important, particularly in patients with a history of allergies and in older patients, considering the possibility of delayed-onset IRRs.

PMID 42719041
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PubMedAAPS PharmSciTech2026-09-10

An Assessment of In Vitro Permeation Testing Finite Dose Methodology.

Zhang Jerry J, Osborne David W DW

Pharmaceutical emulsifiers used in topical products are either non-ionic surfactants or anionic surfactants. Non-ionic emulsifiers are preferred because they minimally extract epidermal lipids from the stratum corneum (SC) and are well tolerated when applied topically. During topical vehicle development, the Franz diffusion cell allows investigators to determine the amount of drug delivered across the SC after topical application. In this study, we characterized extraction and permeation of 10 naturally occurring SC lipids in excised human skin loaded on a Franz cell 24 h after treatment with 4% sodium lauryl sulfate (SLS) aqueous solution versus neat water. Dermatomed human skin was loaded onto vertical Franz cells and chambers were filled with 0.9% NaCl solution. A 7.5-µL dose of water or 4% SLS aqueous solution was added to each Franz cell. Samples were tape stripped, collected, combined, and extracted with 2.0 mL of 1-hexanol/isopropanol/isopropyl myristate/N-methyl-2-pyrrolidone (15/25/20/40 by volume) overnight at 32°C on an orbit shaker. All 10 lipids were recovered from skin in sufficient amounts to be quantitated by liquid chromatography tandem mass spectrometry. Similar amounts of epidermal lipids were extracted from dermis, epidermis, and SC 24 h after dosing with water or 4% SLS, despite varying demographics of the three donors. For the 10 SC lipids characterized in this study, only ceramides showed lag times for appearing in receptor solution of the Franz cells. This study showed that ceramide NP and NS are suitable markers for epidermal lipid extraction after in vitro permeation testing using finite dosing of dermatomed human skin.

PMID 42717125
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PubMedAnnals of thoracic surgery short reports2026-09-10

Presentation and Outcomes of Women and Men After Elective Proximal Aortic Surgery: Retrospective Institutional Analysis.

Picó Ana María AM, Divya Aabha A, Osho Asishana A AA, Hosseini Motahar M et al.

An increasing number of studies are demonstrating how outcomes in women are different from those in men after cardiac surgery. Current research lacks data on the outcomes in elective proximal aortic surgery. We retrospectively reviewed 1299 patients undergoing elective aortic surgery between 2010 and 2023; 347 (27.7%) were women. We examined preoperative and postoperative characteristics and analyzed the data with respect to morbidity and mortality in men compared with women. Demographic data of these cases showed that women had lower body mass index (27.4 kg/m2 vs 28.7 kg/m2; P = .001) and creatinine level (0.882 vs 1.03 mg/dL; P < .001), less hypertension (64.8% vs 74.2%; P = .001), and more chronic obstructive pulmonary disease (8.6% vs 5.1%; P = .028) but similar prevalence of diabetes and smoking. Despite that men had greater procedure length (336 minutes vs 313 minutes; P = .003) and cross-clamp time (134 minutes vs 120 minutes; P < .001), women spent more time in the intensive care unit (83.4 hours vs 55.9 hours; P = .009) and on the ventilator (40.7 hours vs 18.2 hours; P = .021), experienced more postoperative complications (54.8% vs 46.2%; P = .007), and had longer stays (9.73 days vs 7.97 days; P = .002). In-hospital mortality was similar. These results emphasize the need for sex-specific strategies in aortic surgery and further work on identifying the factors that differ between men and women that result in variable outcomes after elective aortic surgery.

PMID 42719105
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PubMedThe journal of physical chemistry letters2026-09-10

Bilayer of Indium Phthalocyanine Molecules on Pb(001): Structure and Spin States.

Ide Niklas N, Banerjee Arnab A, Weismann Alexander A, Robles Roberto R et al.

Bilayers of the nonplanar complex indium phthalocyanine (InPc) were studied on superconducting Pb(001) using scanning tunneling microscopy and density functional theory calculations. The structure of the bilayer is drastically different from that of a single layer in terms of the unit cell, the azimuthal orientations of the molecules, and the position of the In ion above (In↑Pc) or below (In↓Pc) the macrocycle. Intriguingly, the presence of the second layer appears to induce a geometric transition of the first layer. Moreover, a Yu-Shiba-Rusinov state reflecting a localized spin is observed above all molecules of the bilayer.

PMID 42720331
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