Peptides›Sexual / hormonal›Tadalafil

Tadalafil

/ Phosphodiesterase type 5 (PDE-5) inhibitor; β-carboline class

TIER 1 · ClinicalN = 0 · TESTING PENDINGMW 389.40 g·mol⁻¹

ALIAS · Cialis (trade) · Adcirca (trade) · Tadalafil

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Research use onlyAny dose figures below describe what specific cited studies used, reported factually. Nothing on this page is guidance for human use.READ FIRST →

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§ A · Identity

Primary sequence— sequence not captured —

MW · 389.40CLASS · Phosphodiesterase type 5 (PDE-5) inhibitor; β-carboline classCATEGORY · Sexual / hormonal

Tier 1. FDA-approved 2003 for erectile dysfunction (Cialis), subsequently approved for pulmonary arterial hypertension (Adcirca, 2009) and benign prostatic hyperplasia (2011). Distinguished within the PDE-5 inhibitor class by its long half-life (~17.5 hours) supporting the daily-dosing regimen.

§ B · Mechanism of action

Tadalafil selectively inhibits PDE-5 with structural and pharmacokinetic characteristics distinct from sildenafil — substantially longer plasma half-life (~17.5 h vs ~4 h for sildenafil), no PDE-6 cross-reactivity (no visual side effects), and modest PDE-11 cross-reactivity (clinical relevance debated). The long half-life enables daily low-dose use.

§ C · Human clinical evidence

Tier 1. Multiple Phase 3 RCTs across erectile dysfunction (initial approval), PAH (PHIRST trial supported Adcirca), and BPH (Roehrborn 2008 and others).

§ D · Primary literature

PubMed12352386Brock GB et al. — Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses · Journal of Urology · human-phase-3-rctIntegrated analysis of pivotal trials showed tadalafil 10-20 mg significantly improved IIEF erectile function domain and SEP success rates vs placebo across etiologies.Limitations: Industry-sponsored integrated analysis; predominantly mild-to-moderate ED population.2002

PubMed19470885Galiè N et al. — Tadalafil therapy for pulmonary arterial hypertension · Circulation · human-phase-3-rctTadalafil 40 mg once daily improved 6-minute walk distance and time to clinical worsening in pulmonary arterial hypertension (PHIRST trial).Limitations: 16-week trial; long-term morbidity/mortality not assessed in primary period.2009

§ F · Safety signal

Class profile shared with sildenafil minus the visual effects: headache, dyspepsia, back pain (notable for tadalafil specifically), myalgia. Same nitrate contraindication and NAION/SSHL labelling as the class.

§ H · Regulatory status

Regulatory status

FDA status:: FDA-approved
Compounding:: Not eligible for compounding (approved, not in shortage)

§ I · Notable gaps and controversies

Like sildenafil, this is a small molecule not a peptide; 'research peptide' framing is misplaced. Vendor sale outside FDA approved-product channels carries the same safety, identity, and purity concerns that apply to any unapproved-source pharmaceutical.