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Kisspeptin peptides (encoded by the KISS1 gene) occupy an irreplaceable apex position in the regulation of the human hypothalamic-pituitary-gonadal (HPG) axis. First isolated as a metastasis suppressor ("metastin") in malignant melanoma cells, Kisspeptin has evolved into one of the most rigorously investigated neuropeptide families in reproductive endocrinology, hormone-dependent oncological interventions, and neuroendocrine signaling research.
At an industrial procurement level, distinguishing between the primary endogenous isoforms—namely Kisspeptin-54, Kisspeptin-14, Kisspeptin-13, and the widely utilized decapeptide Kisspeptin-10—is crucial for biopharmaceutical drug substance specification. All endogenous kisspeptins share a common C-terminal decapeptide core sequence terminating in a carboxamide group (Tyr-Asn-Trp-Asn-Ser-Phe-Gly-Leu-Arg-Phe-NH2), which represents the minimum pharmacophore required for full nanomolar-affinity binding and activation of the G-protein coupled receptor KISS1R (formerly classified as GPR54).
Engagement of KISS1R by synthetic Kisspeptin activates the canonical Gαq/11 signaling cascade, mobilizing intracellular phospholipase C (PLC), stimulating inositol 1,4,5-trisphosphate (IP3) and diacylglycerol (DAG) turnover, and triggering robust intracellular calcium release. This calcium flux downstream activates protein kinase C (PKC) and mitogen-activated protein kinase (MAPK) pathways (p38 and ERK1/2), ultimately driving the episodic pulsatile exocytosis of gonadotropin-releasing hormone (GnRH) into the hypophyseal portal bloodstream. Consequently, precise quality control over synthetic Kisspeptin API integrity directly impacts the downstream release profiles of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
Thin-Phe-NH2) rather than a free carboxylic acid (-Phe-OH). Deamidated truncated impurities formed during sub-optimal acidolytic cleavage decrease KISS1R receptor activation kinetics by over 1,000-fold, underscoring the requirement for ultra-high performance liquid chromatography (RP-HPLC) coupled with high-resolution electrospray ionization mass spectrometry (ESI-HRMS) batch release verification.
| Isoform / Analog | CAS Registry Number | Amino Acid Sequence | Molecular Weight (Da) | Net Peptide Content | Primary Sourcing Application |
|---|---|---|---|---|---|
| Kisspeptin-10 (KP-10) | 374675-21-5 | H-Tyr-Asn-Trp-Asn-Ser-Phe-Gly-Leu-Arg-Phe-NH2 | 1302.45 g/mol | ≥80.0% (Lyophilized) | HPG Axis Stimulation, IVF Triggering Studies |
| Kisspeptin-54 (Metastin) | 374675-27-1 | GTSLSPPPESSGSRQQPGLSAPHSRQIPAPQGAVLVQREKDLPNYNWNSFGLRF-NH2 | 5857.54 g/mol | ≥75.0% (Lyophilized) | Metastatic Cancer Suppression, LH Secretion Assays |
| Kisspeptin-13 (KP-13) | 374675-23-7 | H-Leu-Pro-Asn-Tyr-Asn-Trp-Asn-Ser-Phe-Gly-Leu-Arg-Phe-NH2 | 1639.84 g/mol | ≥78.0% (Lyophilized) | Endocrine Pharmacokinetics, Signal Transduction |
| Ac-Kisspeptin-10 (Protected) | 1187970-76-2 | Ac-Tyr-Asn-Trp-Asn-Ser-Phe-Gly-Leu-Arg-Phe-NH2 | 1344.48 g/mol | ≥82.0% (Lyophilized) | In Vitro Proteolytic Stability & Enzyme Resistance |
| TAK-448 (MVT-602 Analog) | 1262888-28-7 | Modified Non-Natural Peptide Decapeptide Analog | Synthetic Peptidomimetic | ≥85.0% (Bulk API) | Clinical Hypogonadotropic Hypogonadism Trials |
Chromatographically confirmed minimal baseline noise with total single max unknown impurities <0.5%.
Validated by kinetic turbidimetric Limulus Amebocyte Lysate (LAL) testing for in vivo preclinical workflows.
Hangzhou production infrastructure delivering continuous multi-kilogram campaign reproducibility.
Custom acetate or hydrochloride exchange protocols guaranteeing residual trifluoroacetic acid (TFA) <1.0%.
Strategic procurement executives and contract research organization (CRO) managers must balance purity specifications, salt forms, analytical dossier breadth, and batch scale against budget limits. Kisspeptin peptide pricing does not follow simple commodity chemical modeling; rather, quotations correlate with stereochemical fidelity, counter-ion exchange complexity, and quality assurance overhead.
Industrial pricing transitions markedly across three quality plateaus: Research Grade (>95%), Preclinical Development Grade (>98%), and cGMP Commercial/Clinical Grade (≥99%). Increasing purity from 95% to 99% demands dual-pass preparative reverse-phase chromatography and rigorous fraction-pooling algorithms, requiring higher production budgets while eliminating cross-reactive truncated sequences.
Standard solid-phase cleavage yields peptides as Trifluoroacetate (TFA) salts. Because TFA demonstrates cellular cytotoxicity and disrupts primary cell cultures and in vivo animal models, clients routinely require conversion to Acetate or Hydrochloride salts. This multi-day ion-exchange process increases yield loss and necessitates quantitative IC or GC validation, directly shifting unit quotations.
Quotations encompass complete analytical documentation packages. Standard catalog quotes include 1H-NMR, MS identity, and HPLC purity reports. For IND-enabling preclinical programs and commercial generic launches, our tier-three quotation incorporates comprehensive Stability Indicating Analytical Methods, residual solvent assays, CHN elemental analysis, and complete DMF filing documentation.
| Catalog No. & Target Peptide | Minimum Purity | Salt Form | Standard Quantity | Indicative Price Range (USD) | Standard Lead Time | Included Quality Documentation |
|---|---|---|---|---|---|---|
| TH-KP10-R01 (Kisspeptin-10) | ≥95.0% | TFA Salt | 1 g – 10 g | $220 – $480 / gram | In Stock / 3 Days | CoA, RP-HPLC, MS Confirmation |
| TH-KP10-P02 (Kisspeptin-10) | ≥98.0% | TFA Salt | 50 g – 100 g | $140 – $260 / gram | 1 – 2 Weeks | CoA, RP-HPLC, MS, Water Content (KF) |
| TH-KP10-AC03 (Kisspeptin-10) | ≥98.0% | Acetate Salt (<1% TFA) | 100 g – 500 g | $180 – $320 / gram | 2 – 3 Weeks | Full CoA, HPLC, MS, Residual TFA by IC |
| TH-KP10-GMP (Kisspeptin-10) | ≥99.0% | Acetate / Sterile | 1 kg – 5 kg+ | Custom Commercial Quote | Campaign Scheduled | Full cGMP Dossier, Residual Solvents, Endotoxin |
| TH-KP54-R01 (Kisspeptin-54) | ≥95.0% | TFA Salt | 100 mg – 1 g | $850 – $1,600 / gram | 2 Weeks | CoA, RP-HPLC, High-Res MS, Peptide Content |
| TH-KP54-AC02 (Kisspeptin-54) | ≥98.0% | Acetate Salt | 10 g – 100 g | $650 – $1,200 / gram | 3 – 4 Weeks | CoA, HPLC, MS, AAA, Endotoxin <0.1 EU/mg |
*Disclaimer: Indicative commercial pricing tiers provided for formal enterprise procurement estimation. Custom peptide sequences, isotopic labeling (13C, 15N), and tailored PEGylations require individual project scoping.
The chemical synthesis of high-purity Kisspeptin analogs—specifically long 54-mer metastin structures and hydrophobic decapeptides—presents distinct stereochemical, steric, and physical bottlenecks. Overcoming these barriers requires proprietary solid-phase peptide synthesis (SPPS) optimization, precise cleavage scavenger cocktails, and controlled crystallization technologies.
Utilizing specialized Rink Amide-MBHA and Sieber resins with optimized Fmoc-deprotection kinetics prevents aspartimide formation at the Asn-Trp junctions and eliminates C-terminal carboxylic acid byproduct contamination.
Trp3 in Kisspeptin-10 is uniquely prone to oxidation and electrophilic alkylation during cleavage. We deploy a customized multi-component scavenger matrix (TFA / EDT / Thioanisole / Phenol / H2O) under chilled, oxygen-purged nitrogen blankets.
Arginine (Arg9) and Phenylalanine (Phe6, Phe10) couplings are prone to racemization. We engineer micro-flow reactor heating and OxymaPure/DIC coupling chemistry to suppress D-enantiomer formation below 0.1%.
Using high-throughput C18/C8 spherical stationary phases (100Å–300Å pore size) with axial compression dynamic columns ensures high-resolution separation of closely eluting deletion peptides (des-Gly or des-Phe variants).
Procuring active pharmaceutical ingredients across international borders demands comprehensive regulatory documentation, rigorous cGMP oversight, and temperature-controlled logistics. Thinheal supports global pharmaceutical clients with robust multi-national compliance frameworks.
Every released lot of synthetic Kisspeptin API is subjected to an exhaustive testing panel configured to satisfy ICH Q6A specifications. We do not provide generic release numbers; each shipment is accompanied by raw analytical datasets, including gradient Reverse Phase HPLC chromatograms with expanded integration axes to reveal potential related substances, ESI-MS or MALDI-TOF identity traces confirming intact monoisotopic mass, and Karl Fischer volumetric titration for absolute residual moisture quantification.
For regulatory validation, Amino Acid Analysis (AAA) provides definitive sequence stoichiometry and net peptide content determinations, allowing formulators to calculate exact molar drug concentrations in therapeutic preparations. Residual solvent screening by Headspace Gas Chromatography (GC-FID/MS) verifies compliance with ICH Q3C Class 2 and Class 3 thresholds for residual acetonitrile, dichloromethane, dimethylformamide (DMF), and trifluoroacetic acid.
Our Hangzhou peptide API synthesis campus operates under strict ISO 9001:2015 and ISO 14001 environmental safety certifications, alongside cleanrooms engineered to ISO Class 7 (Class 10,000) and ISO Class 8 (Class 100,000) classifications for terminal lyophilization and packaging. International sponsors are provided with complete audit rights, vendor qualification questionaries, equipment calibration logs, and comprehensive batch manufacturing records (BMR) supporting Investigational New Drug (IND) and Common Technical Document (CTD) Module 3 submissions.
Lyophilized Kisspeptin decapeptides require strict temperature control to prevent secondary hydrolysis and aggregation. All commercial shipments depart our facilities packaged in insulated, high-density polystyrene shipping containers packed with calibrated dry ice or phase-change gel packs maintaining steady -20°C conditions throughout transit. We integrate single-use USB or Bluetooth temperature data loggers inside each consignment, ensuring real-time thermal monitoring across customs checkpoints into North America, the European Union, the United Kingdom, and the Asia-Pacific region.
While natural native Kisspeptin sequences remain central to endocrinological discovery, rapid enzymatic degradation by circulating endopeptidases (such as neprilysin and neutral endopeptidase) yields a short plasma elimination half-life (t1/2 ~ 3–5 minutes for native Kisspeptin-10). The future of synthetic kisspeptin therapeutics centers on biochemical stabilization and intelligent delivery systems.
Mirroring modern GLP-1 pharmacology, conjugated fatty diacid side chains (such as C16 to C20 palmitoyl and stearoyl chains via mini-PEG linkers) enable non-covalent, reversible binding to serum albumin. This shields cleavage hotspots, dramatically extending half-life to enable once-weekly or once-daily dosing regimens.
Introducing alpha,alpha-disubstituted non-natural amino acids with olefinic side chains, followed by ruthenium-catalyzed ring-closing metathesis (RCM), fixes kisspeptin fragments in bioactive alpha-helical or beta-turn geometries. This rigid conformation prevents protease recognition while preserving high KISS1R affinity.
Next-generation metabolic research explores synthetic peptides targeting both KISS1R and the Neurokinin B receptor (NK3R) or neurotensin cascades. These dual-acting chimeric molecules provide coordinated neuroendocrine control over reproductive timing and metabolic energy balance.
Technical, analytical, and commercial guidance addressing common questions raised by quality assurance managers, contract manufacturers, and biopharma sourcing leads.
-Phe-NH2). While both molecules exhibit nanomolar binding affinities for the KISS1R receptor, Kisspeptin-10 is the preferred model peptide for high-throughput in vitro screens and acute in vivo activation due to its efficient synthesis economics, whereas Kisspeptin-54 exhibits greater physiological duration of action in circulation.
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