Phase 3 timeline speculation — when does reta actually hit market

TRIUMPH-4 primary completion is listed as April 2025 on CT.gov last I checked. Data analysis plus NDA submission is usually 6-9 months post-completion. So NDA late 2025/early 2026, approval decision mid-to-late 2026 is plausible. Not late 2026 through mid 2027.

@citation_required good catch, I was conservative. If NDA late 25 and priority review, mid-26 approval is realistic. I was baking in too much slack.

Lilly's been building capacity aggressively in NC and IN. My read is they're planning for reta to launch without tirze being out of the supply hole — they're solving both in parallel. Whether it works is another question.

Meanwhile the research chem channel has had reta available for 18 months already. Real question isn't 'when does it approve' but 'when does payer coverage happen.' Approval means nothing if it's $1500/mo cash.

Zepbound pricing history says it'll be $1000-1200/mo list, maybe $550 with Lilly's direct program, and payer coverage takes 12-24 months after approval to meaningfully broaden. Plan accordingly.

Worth noting — reta for obesity only (TRIUMPH-4) may hit first, diabetes indication second. The compounding pharmacy loophole that's alive for tirze right now will not be available for reta on launch because FDA closed that door in 2024.

So practically speaking, if someone's on research chem reta right now, the economics of switching to pharma reta after approval are bad unless you have good insurance coverage. Planning for multi-year research chem continuity is the realistic move.

Don't forget Novo has cagrisema readouts in the same window. If cagrisema data is competitive, reta's pricing power is weaker on launch. Payers play them against each other.

Lilly cares less about consumer pricing than you'd think — obesity indication for reta is a 10-year franchise play. They'll price for long-term payer contracts not short-term cash pay. Retail cash pay will be brutal for the first 2 years.

Question for the regulatory people — is there precedent for FDA requiring additional cardiovascular outcome trials (like what sema needed) before reta gets a broader label? GCG component is novel and I'd expect CV caution.

@plateau_breaker FDA signaled they want CV outcomes data for the GCG arm specifically. That's TRIUMPH-OUTCOMES which isn't reading until 2028 earliest. Initial approval will likely have language limiting high-risk CV populations.

All speculation downstream of this: if you're waiting for pharma reta before using it, you're waiting 2-4 years for reasonable access. Make your decisions with that in mind rather than assuming 'next year it'll be normal.'

This thread is a better timeline picture than most industry reports I've read. Saving.

Just wanted to say threads like this are why I'm here. Thanks all.

If approval lands mid-26 I'll probably bridge with research chem until my insurance picks it up. Realistic 2028 before I'm paying pharma prices with coverage.

The CV outcomes data thing is the real wildcard nobody talks about enough. Lilly basically has to show reta doesn't spike heart attack risk in obese populations before they can market it hard to the actual patient base that needs it most. That's not some minor label restriction, that's a potential dealbreaker for adoption. If TRIUMPH-OUTCOMES shows anything sketchy, we're talking 2029-2030 before meaningful pharma access and that's assuming they don't just pull the obesity indication altogether.

nah the CV thing is real but lilly already has tirzepatide safety data out to like 104 weeks, reta's gonna be similar molecule. the bigger issue is honestly just manufacturing at scale, they're still catching up on demand and reta's prob gonna have way more hype coming in. mid-27 for obesity sounds about right if nothing goes sideways with the trials tho.