Cialis (Tadalafil) Future Formulations & Pipeline: What's Coming Next

Which tadalafil products are approved right now?

Cialis was approved on 21 November 2003 as a new molecular entity, and a new-indication supplement (BPH) was approved on 6 October 2011 [1]. The label covers ED, the signs and symptoms of BPH, and both together; when Cialis is started with finasteride for BPH, the label recommends use for up to 26 weeks [2].

The 5, 10 and 20 mg tablets are listed as prescription and the 2.5 mg tablet as discontinued, although the current label still describes 2.5 mg once-daily dosing [2][1]. As-needed ED dosing starts at 10 mg, once-daily ED dosing starts at 2.5 mg, and BPH or ED with BPH uses 5 mg once daily [2].

Adcirca is a separate 20 mg tadalafil tablet approved on 22 May 2009 [3]. It is the tadalafil product used for pulmonary arterial hypertension, and the same listing shows Alyq and 20 mg tadalafil tablets from a group of other manufacturers as AB2-rated equivalents [3].

Two newer PAH approvals are also tadalafil products. Tadliq is a tadalafil oral suspension approved in 2022, dosed at 40 mg as 10 mL once daily [6]. Opsynvi is a fixed-dose tablet of macitentan 10 mg plus tadalafil 40 mg, approved in 2024 for chronic pulmonary arterial hypertension in adults in WHO functional class II to III, and it carries a boxed warning for embryo-fetal toxicity from the macitentan component [7].

The combination strategy has trial support, for a different pair

AMBITION assigned 500 treatment-naive adults with PAH in WHO class II or III to ambrisentan 10 mg plus tadalafil 40 mg, ambrisentan alone, or tadalafil alone [4]. Clinical failure occurred in 18% on the combination, 34% on ambrisentan alone and 28% on tadalafil alone, which is 31% for the two monotherapy groups pooled, with a hazard ratio of 0.50 for the combination versus pooled monotherapy (95% CI 0.35 to 0.72, P<0.001) [4]. That trial tested ambrisentan plus tadalafil; it did not test macitentan plus tadalafil, which is the pair in the Opsynvi tablet.

One tadalafil at a time

Cialis and Adcirca contain the same drug, tadalafil, so a person should not take both, and the Cialis label says combinations with other PDE5 inhibitors or other ED treatments have not been studied [2]. The Cialis label contraindicates any form of organic nitrate, and if a nitrate becomes medically necessary in a life-threatening situation, at least 48 hours should pass after the last Cialis dose, with close medical supervision and hemodynamic monitoring [2]. In a 150-man crossover study, tadalafil 20 mg daily still interacted with sublingual nitroglycerin 0.4 mg up to and including 24 hours; at 48 hours the interaction was not seen by most hemodynamic measures [2][5].