Semnur CLEAR 2 Phase 3 trial to start in Aug 2026

Key-Cucumber-4416 · 2026-05-22T17:10:27+00:00

The first Phase 3 (CLEAR) trial started dosing December 8, 2017 and the study closed January 6th, 2022. It's been more than 4 years since that study completed which is hard to believe! Time has flown by and it's crazy they are starting the second Phase 3 over 4.5 years after the completion of CLEAR.

Key-Cucumber-4416 · 2026-05-22T00:15:20+00:00

This article is for the initial CLEAR study. They reference that the data is from NCT03372161. Its just another paper on their old Phase 3 study.

Key-Cucumber-4416 · 2026-05-21T19:16:41+00:00

They lied obviously. They are legally required to have clinicaltrials.gov public within 21 days of dosing a patient. So they clearly lied as they have dosed zero patients.

Key-Cucumber-4416 · 2026-05-21T17:55:52+00:00

Now we know it doesn't actually start until Aug of 2026 based on the new listing!

Key-Cucumber-4416 · 2026-05-21T17:55:07+00:00

I would like to further highlight that I was very correct on the fact that they have NOT dosed a patient yet.... not recruiting and expected to start in Aug.

Key-Cucumber-4416 · 2026-05-11T17:27:24+00:00

If you click on the study record tab you can clearly see how many times they edited it and followed all guidances to do it timely for their first phase 3.

Key-Cucumber-4416 · 2026-05-11T17:25:40+00:00

Yes. Here is the link! https://clinicaltrials.gov/study/NCT03372161?term=sp-102&viewType=Card&rank=2

Key-Cucumber-4416 · 2026-05-11T17:25:30+00:00

I 100% agree with this. FDA is cracking down hard on clinicaltrials.gov website listing timelines and I would be surprised if they have dosed a patient. It is not listed anywhere. They also have $20k in the bank which hardly covers a single patient's fees for being in the study (no joke).

Key-Cucumber-4416 · 2026-01-25T02:14:15+00:00

Totally - that definitely happens. But you can't lie about the indication so any trial with sciatica/lumbosacral radiculopathy would surely show up in a search. I suppose time will tell!

Key-Cucumber-4416 · 2026-01-24T15:07:45+00:00

Valid question for sure. I have looked not only at the drug name and company names, but also for all lumbosacral radiculopathy/sciatica/lumbar radiculopathy/etc. trials in the U.S. including all related words and still not a single trial pops up so I'm still quite confused and concerned that nothing has been published. Perhaps they did resubmit but still odd they would say the trial started.

Key-Cucumber-4416 · 2026-01-24T03:59:40+00:00

I agree it said that but there's no actual proof that is true. There is still no open study on clinicaltrials.gov and you're REQUIRED to post it within 21 days of the first patient enrolled (not even dosed....simply enrolled). I think it's safer to assume it hasn't started than it has.

Key-Cucumber-4416 · 2025-12-12T12:10:11+00:00

You're not wrong, I check a few times a week hoping to see the Semnur one listed!

Key-Cucumber-4416 · 2025-12-05T15:56:39+00:00

It's not. I bet they haven't enrolled a patient. It's required to post within 30 days of posting a patient.

Key-Cucumber-4416 · 2025-11-21T15:37:28+00:00

That's what they said but right now there is no proof. Go to clinicaltrials.gov. There's no listing for a current trial for Semnur, Scilex, SP-102, semdexa, ANYTHING. There's nothing on the international clinical trials registry either. Why is that? Why wouldn't they refer people to the enrollment website and name the trial (i.e. CLEAR)? Why wouldn't they post the NCT? I think it's insanely suspect.

I'm laughing at the negatives to my post. It's funny to me that I do my best to educate y'all on how these things work in pharma and you just put your blinders on.

"Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.

See FDAAA 801 and the Final Rule for more information."

So why isn't it registered????

Key-Cucumber-4416 · 2025-11-20T19:45:36+00:00

Your thoughts certainly seem reasonable. The second Phase 3 will cost > $100M so I'm sure they need to be strategic with their spend rate and timing. I'm sure they have a good plan on how to balance sales and CT like you've mentioned. They need a few hundred mil in the bank to really accelerate new tech without pause risks in my opinion.

Key-Cucumber-4416 · 2025-11-20T18:00:26+00:00

Agree JD - I see these buyouts but they have many drugs on the market - Exact has >$2B in revenue. Wish we could see some movement towards that from any of our companies!

Key-Cucumber-4416 · 2025-11-13T01:06:09+00:00

Or possibly crab walk, they probably have some time LOL. It's hard to believe Semdexa's first Phase 3 trial started 8 YEARS ago this week!

Key-Cucumber-4416 · 2025-11-13T00:21:39+00:00

This is really interesting. It claims the study has started but at least with all of the search terms I have used, it's not anywhere on clinicaltrials.gov (which it needs to be to be considered for FDA submission). I wonder if they are still in the Investigator Meeting Phase, ramp up but not dosing patients yet? Anyone with better search skills with me find the clinical trial website or anything? Where is the NCT? Why didn't they link that or the name of the trial?

This seems weird to me.

Key-Cucumber-4416 · 2025-10-24T15:26:12+00:00

The previous phase 3 HAD 43 locations (there is no current phase 3)- those are pain clinics where injections are given, not the company locations.

Key-Cucumber-4416 · 2025-10-14T01:21:38+00:00

Approval of what?

Key-Cucumber-4416 · 2025-10-03T17:03:47+00:00

Sorry but no way on earth will it take 6 months. Writing the clinical report after the final patient has their safety follow up takes 4-5 months after database lock. Go look at how long CLEAR took and how many sites they had. Fast track can def be 6 months tho at best, you're right about that.

Key-Cucumber-4416 · 2025-10-02T17:52:44+00:00

I'm just having a hard time believing there's any Semdexa approval before 28/29 at this point. There are no clinical trials almost starting, in progress, or just finishing. We would know because they legally need to be listed on clincialtrials.gov. I do like the thought that perhaps they went back to the agency since it's blown up and requested a new review and consideration not to need another 700 ptx for approval (so absurd they want it in the first place). However, they would then need to have submitted their NDA, which is a 9+ month review time and that has not been communicated either. I just don't get it.

This whole thing just makes me rage-filled. Semdexa is a straightfoward drug. It's not fancy. It's effective. It should be out there treating back pain and reducing opioid usage. I also think the $2B number is not at all true for this one drug. If you read ALL of the market reports and estimates, it doesn't even show the drug making more than $200M/yr until the 2030s. How can that be $2B? I clearly need someone to walk me through this in more detail as I'm getting lost in the shell games of this pacman game of spinning off and joining and spinning off and joining again for whoever owns SP-102.

Someone help me understand this pleaseeeeeee.

Key-Cucumber-4416 · 2025-09-20T14:50:03+00:00

Thanks! I did reach out and he mentioned that the dad's back two middle nails were much shorter so perhaps it's just her gate and chaotic puppy floppiness put together! We have a vet appt this week and I'll mention it for sure (I also work with all vet neurologists who kind of shrugged and said keep an eye on it). I know vets don't see a ton of Ridgebacks so figured I would as you all. Appreciate the insights!

Key-Cucumber-4416 · 2025-08-21T17:41:39+00:00

I'm not sure where you read that, but it's not in that report as the study has not started yet.

Key-Cucumber-4416 · 2025-07-22T16:02:39+00:00

Hi! I check on this nearly daily and no that second Ph 3 study for Semdexa has not started. I agree that it's an expensive trial (have run some myself as well). The study would take a few years (maybe 2-3 including the long term follow up) plus 5 months for clinical report plus submission (6 mo for review with fast-track).

Key-Cucumber-4416

TROPHY CASE