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AAV1-FS344 gene therapy vs Kisspeptin side-by-side

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AAV1-FS344 gene therapyKisspeptin

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Wlasciwosc	AAV1-FS344 gene therapy	Kisspeptin
Kategoria	Hormonalne	Hormonalne
Znany tez jako	AAV1.CMV.huFollistatin344, AAV1.CMV.huFS344	Kisspeptin-10, Kisspeptin-54, Metastin
Zatwierdzony przez FDA	Nie	Nie
Status kliniczny	Investigational intramuscular AAV1 follistatin-344 gene-transfer program Pre Przedkliniczne I Faza I II Faza II III Faza III IV Faza IV FDA Zatwierdzone przez FDA	Investigational - Clinical trials ongoing Nie dotyczy
Czego oczekiwac	Muscle growth, myostatin inhibition, body composition	Fertility, testosterone, reproductive hormone optimization
Jak dziala	The AAV1 vector carries a human FS344 expression cassette into skeletal muscle, where the transgene is intended to produce follistatin and reduce activin/myostatin-family signaling. This is gene transfer, not direct administration of a scalar peptide.	Kisspeptin is described as acting through KISS1R/GPR54 receptors on GnRH neurons in the hypothalamus. The reported intracellular pathway includes phospholipase C activation with IP3 and DAG second messengers, followed by increased GnRH release. GnRH then drives pituitary gonadotropin output, including LH and FSH, linking kisspeptin signaling to ovarian and testicular hormone regulation. The source also notes genetic evidence: inactivating KISS1 or KISS1R mutations are associated with pubertal failure and infertility, while activating mutations are associated with precocious puberty.
Typowe dawkowanie	2.4 × 10^12 vector genomes/kg total dose in NCT02354781; investigational protocol, not a dosing recommendation	100-200 mcg subcutaneously once daily · Once daily or every other day
Dawkowanie z badań	2.4 × 10^12 vector genomes/kg total dose · Single administration · 24 months of follow-up · Intramuscular injection	Kisspeptin-10: 1-10 nmol/kg IV · Variable by protocol · IV (research), subcutaneous (investigational)
Typowy czas trwania	24 months of follow-up in NCT02354781	Variable by protocol
Podanie	Intramuscular AAV1 vector administration	IV (research), subcutaneous (investigational)
Timing	-	Morning or as directed With or without food
Poziom dowodów	Badania kliniczne	Badania kliniczne
Mozliwe skutki uboczne	Investigational gene-therapy safety risks require protocol monitoring (The registered study is safety-focused and too small to establish a complete adverse-event profile.)	Generally very well-tolerated (Reported as a general tolerability observation in the source.) No serious adverse events in trials (Source states this for the cited trials; long-term safety is not established.) Temporary flushing (Reported short-term effect.) +3 więcej Mild headache (Reported short-term effect.) Nausea (Reported short-term effect.) Long-term hormonal effects unknown (Source-supported caution about unresolved long-term effects.)
Podsumowanie researchu	NCT02354781 is a small safety-focused study of intramuscular AAV1.CMV.huFollistatin344 gene transfer in Duchenne muscular dystrophy. The protocol distributes a total dose of 2.4 × 10^12 vector genomes/kg across selected muscles and follows participants for 24 months. Efficacy measures are secondary; the record does not establish approved treatment efficacy.	The supplied evidence reports several human research contexts. In women with hypothalamic amenorrhea, subcutaneous kisspeptin-54 was reported to raise LH about 10-fold and FSH about 2.5-fold into the normal range, and infusion protocols were reported to restore LH pulse frequency. In an IVF setting, kisspeptin-54 was used to trigger oocyte maturation, with a live term birth reported, and the source says it has been explored as a potentially gentler trigger with possible ovarian hyperstimulation risk reduction. In hypogonadal men, kisspeptin-10 infusion reportedly increased LH roughly 5-fold and moved testosterone into the normal range. The same source cautions that these data mainly come from small academic studies and specialist infusion protocols, not large multi-center phase 3 trials, and that short-term hormone changes do not establish long-term safety.
Referencje	PMC PubMed +3 więcej PMC ClinicalTrials.gov ClinicalTrials.govAAV1.CMV.huFollistatin344 trial in Duchenne muscular dystrophy	PubMed Central PubMed Central +2 więcej PubMed Central KargerKisspeptin-GPR54 System: What Do We Know About Its Role?
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Wyłącznie edukacyjnie. Te informacje są agregowane z publicznych badań i raportów społeczności. To nie jest poradą medyczną, a informacje o dawkowaniu są opisowe, nie rekomendacyjne. Zawsze konsultuj się z wykwalifikowanym specjalistą ochrony zdrowia.

Wlasciwosc

AAV1-FS344 gene therapy

Kisspeptin

Kategoria

Hormonalne

Znany tez jako

AAV1.CMV.huFollistatin344, AAV1.CMV.huFS344

Kisspeptin-10, Kisspeptin-54, Metastin

Zatwierdzony przez FDA

Nie

Status kliniczny

Investigational intramuscular AAV1 follistatin-344 gene-transfer program

Pre
Przedkliniczne
I
Faza I
II
Faza II
III
Faza III
IV
Faza IV
FDA
Zatwierdzone przez FDA

Investigational - Clinical trials ongoing

Nie dotyczy

Czego oczekiwac

Muscle growth, myostatin inhibition, body composition

Fertility, testosterone, reproductive hormone optimization

Jak dziala

The AAV1 vector carries a human FS344 expression cassette into skeletal muscle, where the transgene is intended to produce follistatin and reduce activin/myostatin-family signaling. This is gene transfer, not direct administration of a scalar peptide.

Kisspeptin is described as acting through KISS1R/GPR54 receptors on GnRH neurons in the hypothalamus. The reported intracellular pathway includes phospholipase C activation with IP3 and DAG second messengers, followed by increased GnRH release. GnRH then drives pituitary gonadotropin output, including LH and FSH, linking kisspeptin signaling to ovarian and testicular hormone regulation. The source also notes genetic evidence: inactivating KISS1 or KISS1R mutations are associated with pubertal failure and infertility, while activating mutations are associated with precocious puberty.

Typowe dawkowanie

2.4 × 10^12 vector genomes/kg total dose in NCT02354781; investigational protocol, not a dosing recommendation

100-200 mcg subcutaneously once daily · Once daily or every other day

Dawkowanie z badań

2.4 × 10^12 vector genomes/kg total dose · Single administration · 24 months of follow-up · Intramuscular injection

Kisspeptin-10: 1-10 nmol/kg IV · Variable by protocol · IV (research), subcutaneous (investigational)

Typowy czas trwania

24 months of follow-up in NCT02354781

Variable by protocol

Podanie

Intramuscular AAV1 vector administration

IV (research), subcutaneous (investigational)

Timing

Morning or as directed

With or without food

Poziom dowodów

Badania kliniczne

Mozliwe skutki uboczne

Investigational gene-therapy safety risks require protocol monitoring (The registered study is safety-focused and too small to establish a complete adverse-event profile.)

Generally very well-tolerated (Reported as a general tolerability observation in the source.)
No serious adverse events in trials (Source states this for the cited trials; long-term safety is not established.)
Temporary flushing (Reported short-term effect.)

+3 więcej

Mild headache (Reported short-term effect.)
Nausea (Reported short-term effect.)
Long-term hormonal effects unknown (Source-supported caution about unresolved long-term effects.)

Podsumowanie researchu

NCT02354781 is a small safety-focused study of intramuscular AAV1.CMV.huFollistatin344 gene transfer in Duchenne muscular dystrophy. The protocol distributes a total dose of 2.4 × 10^12 vector genomes/kg across selected muscles and follows participants for 24 months. Efficacy measures are secondary; the record does not establish approved treatment efficacy.

The supplied evidence reports several human research contexts. In women with hypothalamic amenorrhea, subcutaneous kisspeptin-54 was reported to raise LH about 10-fold and FSH about 2.5-fold into the normal range, and infusion protocols were reported to restore LH pulse frequency. In an IVF setting, kisspeptin-54 was used to trigger oocyte maturation, with a live term birth reported, and the source says it has been explored as a potentially gentler trigger with possible ovarian hyperstimulation risk reduction. In hypogonadal men, kisspeptin-10 infusion reportedly increased LH roughly 5-fold and moved testosterone into the normal range. The same source cautions that these data mainly come from small academic studies and specialist infusion protocols, not large multi-center phase 3 trials, and that short-term hormone changes do not establish long-term safety.

Referencje

PMC PubMed

+3 więcej

PMC ClinicalTrials.gov ClinicalTrials.govAAV1.CMV.huFollistatin344 trial in Duchenne muscular dystrophy

PubMed Central PubMed Central

+2 więcej

PubMed Central KargerKisspeptin-GPR54 System: What Do We Know About Its Role?

Pełny profil

Zobacz szczegóły